+ All Categories
Home > Documents > APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an...

APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an...

Date post: 28-Apr-2018
Category:
Upload: dangtruc
View: 237 times
Download: 5 times
Share this document with a friend
203
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS DR.RUPNATHJI( DR.RUPAK NATH )
Transcript
Page 1: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

APPROVED DRUG PRODUCTS

WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 2: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

APPROVED DRUG PRODUCTS with

THERAPEUTIC EQUIVALENCE EVALUATIONS

PAGE

1.0 INTRODUCTION ........................................................................................................................................ iii 1.1 How to use the Cumulative Supplement ........................................................................................... iii 1.2 Cumulative Supplement Content....................................................................................................... iv 1.3 Applicant Name Changes................................................................................................................... v 1.4 Levothyroxine Sodium...................................................................................................................... .vi 1.5 Availability of the Edition .................................................................................................................. vii 1.6 Report of Counts for the Prescription Drug Product List ..................................................................viii 1.7 Cumulative Supplement Legend ....................................................................................................... ix

DRUG PRODUCT LISTS Prescription Drug Product List ....................................................................................................... 1-1

Drug Products with Approval under Section 505 of the Act

Drug Products Which Must Demonstrate in vivo Bioavailability

OTC Drug Product List .................................................................................................................. 2-1

Administered by the Center for Biologics Evaluation and Research List................................... 3-1 Orphan Product Designations and Approvals List ......................................................................... 4-1

Only if Product Fails to Achieve Adequate Dissolution ............................................................. 5-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM A. Patent and Exclusivity Lists ................................................................................................... A-1 B. Patent and Exclusivity Terms ................................................................................................ B-1

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 3: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

APPROVED DRUG PRODUCTS with

THERAPEUTIC EQUIVALENCE EVALUATIONS

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT

This Cumulative Supplement is one of a series of monthly updates to theApproved Drug Products with Therapeutic Equivalence Evaluations, 30th Edition (the List). The List is composed of four parts: approvedprescription drug products with therapeutic equivalence evaluations;over-the-counter (OTC) drug products that require approved applicationsas a condition of marketing; drug products with approval under Section505 of the Act administered by the Center for Biologics Evaluation andResearch; and products that have never been marketed, are forexportation, are for military use, have been discontinued from marketingor that have had their approvals withdrawn for other than safety orefficacy reasons.

The Cumulative Supplement provides, among other things, information onnewly approved drugs and, if necessary, revised therapeutic equivalenceevaluations and updated patent and exclusivity data. The Addendumcontains appropriate drug patent and exclusivity information required ofthe Agency by the "Drug Price Competition and Patent Term Restoration Actof 1984" for the Prescription, OTC, and Drug Products with Approval underSection 505 of the Act Administered by the Center for BiologicsEvaluation and Research Lists.

Because all parts of the publication are subject to changes, additions,or deletions, the List must be used in conjunction with the most currentCumulative Supplement. Users may wish to mark to the left of theingredient(s) in the List to indicate that changes to that entry appearin the Cumulative Supplement. Drug product information is provided ineach Cumulative Supplement for completeness to assist in locating theproper place in the List for the revision.

The presence of any therapeutic equivalence code indicates that the drugproduct is multisource; the deletion of a therapeutic equivalence codeindicates that the drug product has become single source. (An infrequentexception exists when a therapeutic equivalence code is revised. In that case, the deletion of the therapeutic equivalence code is followedimmediately by the addition of the revised one.)

Products that have never been marketed, are for exportation, are formilitary use, or have been discontinued from marketing or that have hadtheir approvals withdrawn for other than safety or efficacy reasons, willbe flagged in this Cumulative Supplement with the "@" symbol to designatetheir non-marketed status. All products having a "@" symbol in the 12thCumulative Supplement of the 32nd Edition List will then be added to the"Discontinued Drug Product List" appearing in the 33rd Edition. The current Edition Section 2., How To Use The Drug Product Lists, describesthe layout and usage of the List.

iii

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 4: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

New additions to the Prescription Drug Product List and OTC DrugProduct List are indicated by the symbol >A>. The Patent and ExclusivityList new additions are indicated by the symbol >A> to the left of Patent Number or Exclusivity Code. The >A> symbol is then dropped in subsequentCumulative Supplements for that item.

New deletions to the Prescription Drug Product List and OTC Drug ProductList are indicated by the symbol >D> (DELETE) to the left of the line.The information line with the >D> symbol is dropped in subsequentCumulative Supplements for that item.

The Patent and Exclusivity List is arranged in alphabetical order byactive ingredient name(s) and trade name. The trade name will follow the active ingredient name separated by a dash symbol. Also shown is theapplication number and product number (FDA's internal file number) forreference purposes. All patents with their expiration dates aredisplayed for each application number. Drug substance and drug productpatents are indicated as such with DS or DP in the Patent codes column.Use patents are indicated with the symbol "U" followed by a numberrepresenting a specific use. Exclusivity information for a specific drugis indicated by an abbreviation followed by the date upon which theexclusivity expires. Refer to the Exclusivity Terms, Section B, in thePatent and Exclusivity Information Addendum for an explanation of allcodes and abbreviations. Refer to Section 1.3 for internet access to the most current list of Patent and Exclusivity terms.

1.2 CUMULATIVE SUPPLEMENT CONTENT

Since February 2005, we have been providing daily Electronic Orange Book(EOB) product information for new generic drug approvals. Daily genericupdates provide the consumer with the current list of approved genericproducts which is important for substitution purposes. Previously, afirst-time-generic product approved early in the month would not bepublished in the Cumulative Supplement (CS) for several weeks.

The CS monthly update publish goal is by the end of the following month’ssecond work week (e.g., November’s supplement will be updated by the endof the second full work week in December).

Currently, the monthly PDF CS includes:

Generic product ANDA (Abbreviated New Drug Approval) approvals as ofthe date of publication.

All product changes received and processed as of the date ofpublication.o Refer to CS Section 1.8 Cumulative Supplement Legend for

types of changeso Discontinued products will be processed as of the date of

publication. There will be circumstances where a product isdiscontinued in one month, however, it will be reported ina different month's CS. For example, the Orange Book Staffreceived a letter November 7 that the product has beendiscontinued from manufacturing and marketing. The OrangeBook subsequently publishes the October CS on November 14.The product will show in the October CS that it isdiscontinued even though the date of discontinuance is theday that the Orange Book Staff receives notification (November 7).

New Drug Application (NDA) approvals (20,000 and 50,000 series)appear in the CS month they were approved.

iv

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 5: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

Patent information, also updated daily in the EOB, is current tothe date of publication.

Exclusivity information is updated monthly and current to the date ofpublication.

Every effort is made to ensure the Cumulative Supplement is current andaccurate. Applicant holders are requested to inform the FDA Orange BookStaff (OBS) of any changes or corrections. The OBS can be contacted byemail at [email protected]. Send Changes by FAX: 240-276-8974;mail to:

FDA/CDER Orange Book StaffOffice of Generic Drugs, HFD-6107620 Standish Place Rockville, MD 20855-2773

1.3 APPLICANT NAME CHANGES

It is not practical to identify in the Cumulative Supplement each andevery product involved when an applicant transfers its entire line ofapproved drug products to another applicant, or when an applicant changesits name. Therefore, the cumulation of these transfers and name changeswill be identified in this section only. Where only partial lines ofapproved products are transferred between applicants, each approvedproduct involved will appear as an applicant name change entry in theCumulative Supplement.

It is also not practical to identify each and every product involved whenan applicant name is changed to meet internal publication standards(e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectivelyto Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this occurs, each product involved (either currently in the CumulativeSupplement or in the following year's edition) will reflect the newabbreviated name. Consequently, it will not appear as an applicant namechange entry in the Cumulative Supplement nor will the cumulation ofthese name changes appear in this section. The Electronic Orange BookQuery, updated monthly, will contain the most current applicant holdername.

FORMER APPLICANT NAME NEW APPLICANT NAME (FORMER ABBREVIATED NAME) (NEW ABBREVIATED NAME)

ABBOTT LABORATORIES ABBVIE INC (ABBOTT LABS) (ABBVIE)

(ABBOTT) (ABBVIE)

ABBOTT LABORATORIES HOSP PRODUCTS DIV ABBVIE INC (ABBOTT) (ABBVIE)

ABBOTT LABORATORIES PHARMACEUTICAL ABBVIE INC (ABBOTT) (ABBVIE)

ABBOTT PRODUCTS ABBVIE INC (ABBOTT) (ABBVIE)

ABRAXIX PHARMACEUTICAL PRODUCTS FRESENIUS KABI USA LLC (ABRAXIS PHARM) (FRESENIUS KABI USA)

ALCON UNIVERSAL LTD ALCON PHARMACEUTICALS LTD (ALCON UNIVERSAL) (ALCON PHARMS LTD)

v

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 6: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

APP PHARMACEUTICALS FRESENIUS KABI USA LLC (APP PHARMS (FRESENIUS KABI USA)

APP PHARMACEUTICALS LLC FRESENIUS KABI USA LLC (APP PHARMS) (FRESENIUS KABI USA)

FOREST LABORATORIES PFIZER INC (FOREST LABS) (PFIZER)

NEXUS PHARMACEUTICALS FRESENIUS KABI USA LLC (NEXUS PHARMS) (FRESENIUS KABI USA)

OVATION PHARMACEUTICALS INC OAK PHARMACEUTICALS INC (OVATION PHARMS) (OAK PHARMS)

PFIZER CONSUMER HEALTHCARE PFIZER INC (PFIZER CONS HLTHCARE) (PFIZER)

ROSS LABORATORIES DIV ABBOTT ABBVIE INC LABORATORIES (ROSS LABS) (ABBVIE)

SOLVAY PHARMACEUTICALS ABBVIE INC (SOLVAY) (ABBVIE)

UNIMED PHARMACEUTICALS INC ABBVIE INC (UNIMED PHARMS) (ABBVIE)

WYETH CONSUMER HEALTHCARE PFIZER INC (WYETH CONS) (PFIZER)

1.4 LEVOTHYROXINE SODIUM

Because there are multiple reference listed drugs of levothyroxine sodiumtablets and some reference listed drugs' sponsors have conducted studiesto establish their drugs' therapeutic equivalence to other referencelisted drugs, FDA has determined that its usual practice of assigning twoor three character TE codes may be potentially confusing and inadequatefor these drug products. Accordingly, FDA provides the followingexplanation and chart of therapeutic equivalence evaluations forlevothyroxine sodium drug products.

Levothyroxine Sodium (Mylan ANDA 76187) and Levo-T (Alara NDA 21342)tablets have been determined to be therapeutically equivalent tocorresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets.Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187),Unithroid (Jerome Stevens NDA 021210), and Levothyroxine Sodium (MerckKGAA ANDA 76752)tablets have been determined to be therapeuticallyequivalent to corresponding strengths of Synthroid (Abbott NDA 021402)tablets.

Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210),Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (MerckKGAA ANDA 76752) tablets have been determined to be therapeuticallyequivalent to corresponding strengths of Levoxyl (King Pharms NDA 021301)tablets.

Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined tobe therapeutically equivalent to corresponding strengths of Levothroid(Lloyd NDA 021116) tablets.

The chart outlines TE codes for all 0.025mg products. Other productstrengths may be similar. Therapeutic equivalence has been established

vi

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 7: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

between products that have the same AB+number TE code. More than oneTE code may apply to some products. One common TE code indicatestherapeutic equivalence between products.

Trade Name Applicant Potency TE Code Appl No Product No UNITHROID STEVENS J 0.025MG AB1 21210 001 LEVOTHYROXINE SODIUM

MYLAN 0.025MG AB1 76187 001

LEVOXYL KING PHARMS 0.025MG AB1 21301 001 SYNTHROID ABBOTT 0.025MG AB1 21402 001 LEVO-T ALARA PHARM 0.025MG AB1 21342 001

SYNTHROID ABBOTT 0.025MG AB2 21402 001 LEVOTHYROXINE SODIUM

MYLAN 0.025MG AB2 76187 001

LEVO-T ALARA PHARM 0.025MG AB2 21342 001 UNITHROID STEVENS J 0.025MG AB2 21210 001 LEVOTHYROXINE SODIUM

MERCK KGAA 0.025MG AB2 76752 001

LEVOXYL KUNG PHARMS 0.025MG AB3 21301 001 LEVO-T ALARA PHARM 0.025MG AB3 21342 001 UNITHROID STEVENS J 0.025MG AB3 21210 001 LEVOTHYROXINE SODIUM

MYLAN 0.025MG AB3 76187 001

LEVOTHYROXINE SODIUM

MERCK KGAA 0.025MG AB3 76752 001

LEVOTHROID LLOYD 0.025MG AB4 21116 001 LEVOTHYROXINE SODIUM

MYLAN 0.025MG AB4 76187 001

1.5 AVAILABILITY OF THE EDITION

Since 1997, the Electronic Orange Book Query (EOBQ)http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm, has been available on the internet and has become the updated-every-month OrangeBook. The Query provides searching of the approved drug list by activeingredient, proprietary name, applicant holder, applicant number or patentnumber. Product search categories are: prescription, over-the-counter,discontinued drugs. There are links to patent and exclusivity informationthat may be applicable to each product.

Commencing with the 25th edition, the Annual Edition and monthlyCumulative Supplements have been provided in downloadable PortableDocument Format (PDF) at the EOB home page by clicking on Publications.The PDF annual and cumulative supplements duplicate previous paperversions. Over time, there will be an archive for the annuals and eachyear's December Cumulative Supplement.

The downloaded Annual Edition and Cumulative Supplements are alsoavailable in a paper version (Approved Drug Products with TherapeuticEquivalence Evaluations, ADP) from the U.S. Government Printing Office:http://bookstore.gpo.gov; toll free 866-512-1800.

There are historical lists of Orange Book cumulative supplement productmonthly changes athttp://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm. There are ASCII text files of the Orange Book drug product, patent, and exclusivitydata at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm. The drug product text files are provided in eobzip.zip format. The files areupdated concurrently with the monthly cumulative supplements. The annual

vii

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 8: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

Orange Book Edition Appendices A, B, and C in PDF format are updatedquarterly.

Effective August 18, 2003, patent submissions for publication in theOrange Book and Docket *95S-0117 need to be submitted on form FDA-3542which may be downloaded from the FDA Forms List,http://www.fda.gov/opacom/morechoices/fdaforms/default.html.

The current listing of the Orphan Product Designations and Approvals isavailable at http://www.fda.gov/orphan/designat/list.htm.

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

DESCRIPTION OF REPORT

This report provides summary counts derived from the product informationin the Prescription Drug Product List and the current CumulativeSupplement. Products included in the counts are domestically marketeddrug products approved for both safety and effectiveness under section505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approveddrug products marketed by distributors; those marketed solely abroad; andthose now regarded as medical devices, biologics or foods.

The baseline column (Dec 2011) refers to the products in the PrescriptionDrug Product List. For each three-month period, a column of quarterlydata is added which incorporates counts of product activity from theprevious quarter(s) with those in the baseline count.

DEFINITIONS

Drug Product

For this report, a drug product is the representation in the PrescriptionDrug Product List of an active moiety (molecular entity and its salts,esters and derivatives) either as a single ingredient or as a combinationproduct provided in a specific dosage form and strength for a given routeof administration with approval for marketing by a firm under aparticular generic or trade name.

New Molecular Entity

A new molecular entity is considered an active moiety that has notpreviously been approved (either as the parent compound or as a salt,ester or derivative of the parent compound) in the United States for usein a drug product either as a single ingredient or as part of acombination.

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST COUNTS CUMULATIVE BY QUARTER

CATEGORIES COUNTED DEC 2011 MAR 2012 JUN 2012 SEPT 2012 DEC 2012

DRUG PRODUCTS LISTED 14480 14711 14834 15160 SINGLE SOURCE 2451 2446 2428 2429

MULTISOURCE (16.9%)11953

(16.6%)12187

(16.4%)12328

(16.0%)12653

THERAPEUTICALLY (82.5%)11792

(82.8%)12037

(83.1%)12187

(83.5%)12509

EQUIVALENT (81.4%) (81.8%) (82.2%) (82.5%)

viii

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 9: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

NOT THERAPEUTICALLY 161 150 141 144 EQUIVALENT (1.1%) (1.0%) (1.0%) (0.9%)

EXCEPTIONS1 76 78 78 78 (0.5%) (0.5%) (0.5%) (0.5%)

NEW MOLECULAR ENTITIES APPROVED 6 8 7 9

NUMBER OF APPLICANTS 810 826 826 836

1Amino acid-containing products of varying composition (see Introduction, page xx of the List).

1.7 CUMULATIVE SUPPLEMENT LEGEND

The List is sorted by Ingredient(s) and, within each grouping, by theDosage Form; Route and then by trade name.

The individual product record contains the Therapeutic Equivalence Code,Reference Listed Drug symbol, applicant holder, strength(s), New DrugApplication number, product number, and approval date. The applicationnumber preceded by “N” is a New Drug Application (NDA or innovator). The application number preceded by an “A” is an Abbreviated New DrugApplication (ANDA or generic). The last two columns describe the action. The Action Month is the CS month the action occurred. The OB Action is the type of change that has occurred.

New ingredient(s), new dosage form; route(s), new trade names, and newproduct additions are preceded by >A> during the action month. The changemonth is the current CS month; the change code for new approvals is NEWA.Following months will display the same information without the >A>.

Changes to currently listed products will list two records. The deleted product record will be proceeded by >D>. The product record changeaddition being made will be preceded by >A>. Following months willdisplay only the >A> record without the >A>. All changes that occur tothe product through the Annual year will be listed. The change month andchange code will document the change.

The change code and description:

NEWA New drug product approval usually in the supplementmonth.

CAHN Applicant holder firm name has changed.CAIN Change. There has been a change in the Ingredient(s) name.

All products will be deleted under the old name and allproducts will be added under the changed ingredient(s) name.

CDFR Change. Dosage Form; Route of Administration.CFTG Change. A first time generic for the innovator product. A

TE Code is added. CMFD Change. The product is moved from the Discontinued Section

due to a change in marketing status.CMS1 Change. Miscellaneous addition to list.CMS2 Change. Miscellaneous deletion from list.CPOT Change. Potency amount/unit.CRLD Change. Reference Listed Drug.CTEC Change. Therapeutic Equivalence Code.CTNA Change. Trade Name.DISC Discontinued. The Rx or OTC listed product is not

being marketed and will be moved to the discontinuedsection in the next edition.

ix

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 10: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

PRESCRIPTION DRUG PRODUCT LIST - 32ND EDITION

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-1

ABACAVIR SULFATE

TABLET; ORAL ABACAVIR SULFATE

AB MYLAN PHARMS INC EQ 300MG BASE

ZIAGEN AB + VIIV HLTHCARE EQ 300MG BASE

ACARBOSE

TABLET; ORAL ACARBOSE

AB EMCURE PHARMS LTD 25MG

AB 50MG

AB 100MG

ACETAMINOPHEN; BUTALBITAL

TABLET; ORAL

BUTAPAP + MIKART 325MG;50MG

PHRENILIN

@ VALEANT 325MG;50MG

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

AA LANNETT HOLDINGS INC 325MG;50MG;40MG

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

NEXGEN PHARMA INC 300MG;50MG;40MG;30MG

ACETAMINOPHEN; CODEINE PHOSPHATE

SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE

AA + PHARM ASSOC 120MG/5ML;12MG/5ML

SUSPENSION; ORAL CAPITAL AND CODEINE

+ VALEANT 120MG/5ML;12MG/5ML

+ VALEANT PHARMS LLC 120MG/5ML;12MG/5ML

ACETAMINOPHEN; HYDROCODONE BITARTRATE

SOLUTION; ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN @ NESHER PHARMS 500MG/15ML;7.5MG/15ML

AA VISTAPHARM 325MG/15ML;7.5MG/15ML

TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN

AA AUROLIFE PHARMA LLC 325MG;5MG

AA 325MG;7.5MG

AA 325MG;10MG

@ VINTAGE PHARMS LLC 500MG;5MG

@ 500MG;7.5MG

@ 650MG;7.5MG

A091294

N020977

A202271

A202271

A202271

A089987

A087811

A200243

A076560

A087508

A086024

A086024

A040366

A200343

A201013

A201013

A201013

A040281

A040280

A040280

001

001

001

002

003

001

001

001

002

001

001

001

001

001

001

002

003

001

001

002

JunJun 18, 2012 NEWA

JunDec 17, 1998 CFTG

JanFeb 07, 2012 NEWA

JanFeb 07, 2012 NEWA

JanFeb 07, 2012 NEWA

JunOct 26, 1992 CRLD

JunJun 19, 1985 DISC

AugSep 13, 2012 NEWA

JulJul 19, 2012 NEWA

Jan CRLD

Jan CTEC

Jun CAHN

JunJan 23, 2002 DISC

JanJan 25, 2012 NEWA

MarApr 11, 2012 NEWA

MarApr 11, 2012 NEWA

MarApr 11, 2012 NEWA

SepSep 30, 1998 CAHN

SepSep 30, 1998

SepSep 30, 1998

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 11: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-2

TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN @ VINTAGE PHARMS LLC

@

VICODIN

650MG;10MG

750MG;7.5MG

A040280

A040281

003

002

Sep 30, 1998

Sep 30, 1998

Sep

Sep

CAHN

CAHN

>D>

>A>

AA

AA

+

+

ABBVIE

@

VICODIN ES

500MG;5MG

500MG;5MG

500MG;5MG

A088058

A088058

A088058

001

001

001

Jan 07, 1983

Jan 07, 1983

Jan 07, 1983

Nov

Nov

Sep

DISC

DISC

CAHN

>D>

>A>

AA

AA

+

+

ABBVIE

@

VICODIN HP

750MG;7.5MG

750MG;7.5MG

750MG;7.5MG

A089736

A089736

A089736

001

001

001

Dec 09, 1988

Dec 09, 1988

Dec 09, 1988

Nov

Nov

Sep

DISC

DISC

CAHN

>D>

>A>

AA

AA

ABBVIE

@

ZYDONE

660MG;10MG

660MG;10MG

660MG;10MG

A040117

A040117

A040117

001

001

001

Sep 23, 1996

Sep 23, 1996

Sep 23, 1996

Nov

Nov

Sep

DISC

DISC

CAHN

+

+

+

VINTAGE PHARMS LLC 400MG;5MG

400MG;7.5MG

400MG;10MG

A040288

A040288

A040288

001

002

003

Nov 27, 1998

Nov 27, 1998

Nov 27, 1998

Sep

Sep

Sep

CAHN

CAHN

CAHN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN @ VINTAGE PHARMS LLC 500MG;5MG

TABLET; ORAL OXYCODONE AND ACETAMINOPHEN

A040303 001 Dec 30, 1999 Sep CAHN

AA

AA

AA

AA

ACTAVIS TOTOWA

ALVOGEN INC

PERCOCET

325MG;7.5MG

325MG;10MG

325MG;7.5MG

325MG;10MG

A040800

A040800

A202677

A202677

001

002

001

002

Apr 03, 2012

Apr 03, 2012

Jul 26, 2012

Jul 26, 2012

Mar

Mar

Jul

Jul

NEWA

NEWA

NEWA

NEWA

AA

AA

AA

AA

AA

AA

+

+

+

+

+

+

@

VINTAGE PHARMS LLC 325MG;2.5MG

325MG;5MG

325MG;5MG

325MG;7.5MG

325MG;10MG

500MG;7.5MG

650MG;10MG

A040330

A040330

A085106

A040434

A040434

A040341

A040341

001

002

002

001

002

001

002

Jun 25, 1999

Jun 25, 1999

Nov 23, 2001

Nov 23, 2001

Jul 26, 1999

Jul 26, 1999

Sep

Sep

Sep

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

TABLET; ORAL WYGESIC @ CARACO 650MG;65MG A084999 001 Oct CAHN

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

TABLET; ORAL TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

AB

AB

ALVOGEN INC

ZYDUS PHARMS USA INC

325MG;37.5MG

325MG;37.5MG

A202076

A090460

001

001

Mar 30, 2012

Sep 06, 2012

Mar

Aug

NEWA

NEWA

ACETAZOLAMIDE SODIUM

INJECTABLE; INJECTION ACETAZOLAMIDE SODIUM

AP

AP +

SAGENT STRIDES

X GEN PHARMS

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

A200880

A040784

001

001

May 09, 2012

Dec 10, 2008

Apr

Apr

NEWA

CRLD

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 12: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-3

INJECTABLE; INJECTION DIAMOX @ TEVA WOMENS EQ 500MG BASE/VIAL N009388 001 Dec 05, 1990 Apr DISC

ACETYLCYSTEINE

INJECTABLE; INTRAVENOUS ACETADOTE

AP + CUMBERLAND PHARMS

ACETYLCYSTEINE

6GM/30ML (200MG/ML) N021539 001 Jan 23, 2004 Oct CFTG

AP INNOPHARMA INC 6GM/30ML (200MG/ML)

SOLUTION; INHALATION, ORAL ACETYLCYSTEINE

A200644 001 Nov 07, 2012 Oct NEWA

AN INNOPHARMA INC 20% A203853 001 Jun 21, 2012 Jun NEWA

ACLIDINIUM BROMIDE

POWDER, METERED; INHALATION TUDORZA PRESSAIR

+ FOREST LABS INC 0.375MG/INH N202450 001 Jul 23, 2012 Jul NEWA

ACYCLOVIR

CAPSULE; ORAL ACYCLOVIR @ HERITAGE PHARMS INC

TABLET; ORAL ACYCLOVIR

200MG A074889 001 Oct 31, 1997 May CAHN

@ HERITAGE PHARMS INC

@

400MG

800MG

A074891

A074891

001

002

Oct 31, 1997

Oct 31, 1997

May

May

CAHN

CAHN

ACYCLOVIR SODIUM

INJECTABLE; INJECTION ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

+ HIKMA MAPLE

ACYCLOVIR SODIUM

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

A074885

A074885

001

002

Dec 19, 1997

Dec 19, 1997

Oct

Oct

CAHN

CAHN

AP

AP

HIKMA MAPLE EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

A074913

A074913

001

002

Oct 15, 1997

Oct 15, 1997

Oct

Oct

CAHN

CAHN

ADAPALENE

CREAM; TOPICAL ADAPALENE

AB FOUGERA PHARMS

GEL; TOPICAL ADAPALENE

0.1% A090824 001 Jun 30, 2010 Jan CAHN

AB TOLMAR

DIFFERIN

0.3% A200298 001 Jun 14, 2012 Jun NEWA

AB + GALDERMA LABS LP

LOTION; TOPICAL DIFFERIN

0.3% N021753 001 Jun 19, 2007 Jun CFTG

+ GALDERMA LABS LP 0.1% N022502 001 Mar 17, 2010 Apr CAHN

ADENOSINE

INJECTABLE; INJECTION ADENOSINE

AP

@ HIKMA MAPLE

@ TEVA PARENTERAL

3MG/ML

3MG/ML

3MG/ML

A076501

A076500

A078676

001

001

001

Jun 16, 2004

Jun 16, 2004

Jul 31, 2008

Oct

Oct

Mar

CAHN

CAHN

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 13: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-4

INJECTABLE; INJECTION ADENOSINE @ TEVA PARENTERAL 3MG/ML A076564 001 Jun 16, 2004 Jan DISC

ALBUTEROL SULFATE

SOLUTION; INHALATION ALBUTEROL SULFATE

AN TEVA PHARMS EQ 0.083% BASE A075343 001 Nov 09, 1999 Sep CAHN

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

SOLUTION; INHALATION ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

AN

AN

RITEDOSE CORP

@ SANDOZ INC

TEVA PHARMS

EQ 0.083% BASE;0.017%

EQ 0.083% BASE;0.017%

EQ 0.083% BASE;0.017%

A202496

A076867

A076724

001

001

001

Oct 01, 2012

Dec 21, 2006

Dec 31, 2007

Sep

Apr

Sep

NEWA

DISC

CAHN

ALCLOMETASONE DIPROPIONATE

CREAM; TOPICAL ALCLOMETASONE DIPROPIONATE

AB FOUGERA PHARMS 0.05%

OINTMENT; TOPICAL ALCLOMETASONE DIPROPIONATE

A076973 001 Jul 12, 2005 Jan CAHN

AB FOUGERA PHARMS 0.05% A076884 001 Jul 18, 2005 Jan CAHN

ALENDRONATE SODIUM

TABLET, EFFERVESCENT; ORAL BINOSTO

+ MISSION PHARMA EQ 70MG BASE N202344 001 Mar 12, 2012 Mar NEWA

ALFUZOSIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL ALFUZOSIN HYDROCHLORIDE

AB

AB

AB

AUROBINDO PHARMA LTD

INVAGEN PHARMS

WOCKHARDT LTD

10MG

10MG

10MG

A079060

A090284

A090221

001

001

001

Aug 30, 2012

Jan 17, 2012

Aug 10, 2012

Aug

Jan

Jul

NEWA

NEWA

NEWA

ALGLUCERASE

INJECTABLE; INJECTION CEREDASE @ GENZYME 80 UNITS/ML N020057 003 Apr 05, 1991 Mar DISC

ALPRAZOLAM

TABLET; ORAL ALPRAZOLAM

AB

AB

AB

AB

MYLAN PHARMS INC 0.25MG

0.5MG

1MG

2MG

TABLET, EXTENDED RELEASE; ORAL ALPRAZOLAM

A074046

A074046

A074046

A074046

001

002

003

004

Oct 19, 1993

Oct 19, 1993

Oct 19, 1993

May 07, 1997

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

@ SANDOZ INC

@

@

@

@ VINTAGE PHARMS

@

0.5MG

1MG

2MG

3MG

0.5MG

1MG

A077777

A077777

A077777

A077777

A078442

A078442

001

002

003

004

001

002

Jun 30, 2006

Jun 30, 2006

Jun 30, 2006

Jun 30, 2006

Oct 15, 2007

Oct 15, 2007

Mar

Mar

Mar

Mar

Jul

Jul

DISC

DISC

DISC

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 14: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-5

TABLET, EXTENDED RELEASE; ORAL ALPRAZOLAM @ VINTAGE PHARMS 2MG

@ 3MG

TABLET, ORALLY DISINTEGRATING; ORAL NIRAVAM

A078442

A078442

003

004

Oct 15, 2007

Oct 15, 2007

Jul

Jul

DISC

DISC

AB

AB

AB

AB

+

UCB INC 0.25MG

0.5MG

1MG

2MG

N021726

N021726

N021726

N021726

001

002

003

004

Jan 19, 2005

Jan 19, 2005

Jan 19, 2005

Jan 19, 2005

Jan

Jan

Jan

Jan

CAHN

CAHN

CAHN

CAHN

ALVIMOPAN

CAPSULE; ORAL ENTEREG

+ CUBIST PHARMS 12MG N021775 001 May 20, 2008 Feb CAHN

AMCINONIDE

CREAM; TOPICAL AMCINONIDE

AB + FOUGERA PHARMS

LOTION; TOPICAL AMCINONIDE

0.1% A076065 001 May 15, 2003 Jan CAHN

+ FOUGERA PHARMS

OINTMENT; TOPICAL AMCINONIDE

0.1% A076329 001 Nov 06, 2002 Jan CAHN

AB + FOUGERA PHARMS 0.1% A076096 001 Nov 19, 2002 Jan CAHN

AMIKACIN SULFATE

INJECTABLE; INJECTION AMIKACIN SULFATE @ HIKMA MAPLE

@

@ HOSPIRA

EQ 50MG BASE/ML

EQ 250MG BASE/ML

EQ 50MG BASE/ML

A063274

A063275

A063263

001

001

001

May 18, 1992

May 18, 1992

Nov 30, 1994

Oct

Oct

Jun

CAHN

CAHN

DISC

AMINO ACIDS

INJECTABLE; INJECTION AMINO ACIDS

B BRAUN 15%(150GM/1000ML)

15%(300GM/2000ML)

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER

A091112

A091112

001

002

Apr 13, 2012

Apr 13, 2012

Mar

Mar

NEWA

NEWA

BAXTER HLTHCARE

NOVAMINE 15%

15% (15GM/100ML) A020512 001 Aug 30, 1996 Jun CAHN

@ HOSPIRA INC 15% (75GM/500ML) N017957 004 Nov 28, 1986 Mar CPOT

AMINOCAPROIC ACID

INJECTABLE; INJECTION AMICAR @ CLOVER PHARMS

SYRUP; ORAL AMICAR

250MG/ML N015229 002 Mar CAHN

AA + CLOVER PHARMS

TABLET; ORAL AMICAR

1.25GM/5ML N015230 002 Mar CAHN

AB CLOVER PHARMS 500MG N015197 001 Mar CAHN

+ 1GM N015197 002 Jun 24, 2004 Mar CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 15: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-6

AMIODARONE HYDROCHLORIDE

INJECTABLE; INJECTION AMIODARONE HYDROCHLORIDE @ BEDFORD 50MG/ML

@ BEDFORD LABS 50MG/ML

@ TEVA PARENTERAL 50MG/ML

TABLET; ORAL AMIODARONE HYDROCHLORIDE

A076018

A076299

A076163

001

001

001

Oct 15, 2002

Oct 24, 2002

Sep 05, 2003

Jun

Jun

Jan

DISC

DISC

DISC

AB

AB

MURTY PHARMS 200MG

400MG

A077069

A077069

001

002

Apr 08, 2005

Apr 08, 2005

May

May

CAHN

CAHN

AMITRIPTYLINE HYDROCHLORIDE

TABLET; ORAL AMITRIPTYLINE HYDROCHLORIDE

AB

AB

AB

AB

AB

CARACO 10MG

50MG

75MG

100MG

150MG

A040816

A040816

A040816

A040816

A040816

002

003

004

005

006

Jun 27, 2008

Jun 27, 2008

Jun 27, 2008

Jun 27, 2008

Jun 27, 2008

Apr

Apr

Apr

Apr

Apr

NEWA

NEWA

NEWA

NEWA

NEWA

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET; ORAL CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

+

MYLAN PHARMS INC

LIMBITROL

EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

A071297

A071297

002

001

Dec 10, 1986

Dec 10, 1986

Feb

Feb

CTEC

CRLD

@ VALEANT PHARM INTL

LIMBITROL DS

EQ 12.5MG BASE;5MG N016949 001 Feb DISC

@ VALEANT PHARM INTL EQ 25MG BASE;10MG N016949 002 Feb DISC

AMLODIPINE BESYLATE

TABLET; ORAL AMLODIPINE BESYLATE

AB

AB

MACLEODS PHARMS LTD

@ SANDOZ

@

@

EQ 5MG BASE

EQ 10MG BASE

EQ 2.5MG BASE

EQ 5MG BASE

EQ 10MG BASE

A201380

A201380

A076859

A076859

A076859

001

002

001

002

003

Apr 13, 2012

Apr 13, 2012

Sep 10, 2007

Sep 10, 2007

Sep 10, 2007

Mar

Mar

Oct

Oct

Oct

NEWA

NEWA

DISC

DISC

DISC

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE; ORAL AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AUROBINDO PHARMA LTD EQ 2.5MG BASE;10MG

EQ 5MG BASE;10MG

EQ 5MG BASE;20MG

EQ 5MG BASE;40MG

EQ 10MG BASE;20MG

EQ 10MG BASE;40MG

A202239

A202239

A202239

A202239

A202239

A202239

001

002

003

004

005

006

Sep 05, 2012

Sep 05, 2012

Sep 05, 2012

Sep 05, 2012

Sep 05, 2012

Sep 05, 2012

Aug

Aug

Aug

Aug

Aug

Aug

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET; ORAL EXFORGE HCT

AB

AB

AB

NOVARTIS 5MG;12.5MG;160MG

5MG;25MG;160MG

10MG;12.5MG;160MG

N022314

N022314

N022314

001

002

003

Apr 30, 2009

Apr 30, 2009

Apr 30, 2009

Sep

Sep

Sep

CFTG

CFTG

CFTG

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 16: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-7

TABLET; ORAL EXFORGE HCT

AB NOVARTIS 10MG;25MG;160MG N022314 004 Apr 30, 2009 Sep CFTG

AB + 10MG;25MG;320MG N022314 005 Apr 30, 2009 Sep CFTG

AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET; ORAL AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE

AB TEVA PHARMS 5MG;12.5MG;160MG A200435 001 Sep 25, 2012 Sep NEWA

AB 5MG;25MG;160MG A200435 002 Sep 25, 2012 Sep NEWA

AB 10MG;12.5MG;160MG A200435 005 Sep 25, 2012 Sep NEWA

AB 10MG;25MG;160MG A200435 003 Sep 25, 2012 Sep NEWA

AB 10MG;25MG;320MG A200435 004 Sep 25, 2012 Sep NEWA

AMMONIUM LACTATE

CREAM; TOPICAL AMMONIUM LACTATE

AB WATSON LABS INC EQ 12% BASE A076829 001 Feb 07, 2006 Oct CAHN

LOTION; TOPICAL AMMONIUM LACTATE

AB WATSON LABS INC EQ 12% BASE A075575 001 Jun 11, 2002 Oct CAHN

AMOXICILLIN

CAPSULE; ORAL AMOXICILLIN

AB AM ANTIBIOTICS 250MG A062058 001 Oct CAHN

AB 500MG A062058 002 Oct CAHN

TABLET, FOR SUSPENSION; ORAL DISPERMOX @ RANBAXY LABS LTD 600MG A065159 001 Dec 04, 2003 Apr DISC

AMOXICILLIN; CLAVULANATE POTASSIUM

FOR SUSPENSION; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM

AB SANDOZ INC 200MG/5ML;EQ 28.5MG BASE/5ML A065098 001 Dec 16, 2002 Jul CAHN

AB 400MG/5ML;EQ 57MG BASE/5ML A065098 002 Dec 16, 2002 Jul CAHN

AB 600MG/5ML;EQ 42.9MG BASE/5ML A065358 001 Aug 13, 2007 Jul CAHN

TABLET; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM

AB AUROBINDO PHARMA LTD 250MG;EQ 125MG BASE A091569 001 Jan 20, 2012 Jan NEWA

AB 500MG;EQ 125MG BASE A091569 002 Jan 20, 2012 Jan NEWA

AB 875MG;EQ 125MG BASE A091568 001 Jan 20, 2012 Jan NEWA

AB SANDOZ INC 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002 Jul CAHN

AB 875MG;EQ 125MG BASE A065093 001 Nov 21, 2002 Jul CAHN

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE; ORAL ADDERALL XR 10

AB SHIRE 2.5MG;2.5MG;2.5MG;2.5MG N021303 001 Oct 11, 2001 Jun CFTG

ADDERALL XR 15 AB SHIRE 3.75MG;3.75MG;3.75MG;3.75MG N021303 006 May 22, 2002 Jun CFTG

ADDERALL XR 20 AB SHIRE 5MG;5MG;5MG;5MG N021303 002 Oct 11, 2001 Jun CFTG

ADDERALL XR 25 AB SHIRE 6.25MG;6.25MG;6.25MG;6.25MG N021303 004 May 22, 2002 Jun CFTG

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 17: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-8

CAPSULE, EXTENDED RELEASE; ORAL ADDERALL XR 30

AB + SHIRE

ADDERALL XR 5

7.5MG;7.5MG;7.5MG;7.5MG N021303 003 Oct 11, 2001 Jun CFTG

AB

AB

AB

AB

AB

AB

AB

SHIRE 1.25MG;1.25MG;1.25MG;1.25MG 005 N021303

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ACTAVIS ELIZABETH 1.25MG;1.25MG;1.25MG;1.25MG 001 A077302

2.5MG;2.5MG;2.5MG;2.5MG 002 A077302

3.75MG;3.75MG;3.75MG;3.75MG 003 A077302

5MG;5MG;5MG;5MG 004 A077302

6.25MG;6.25MG;6.25MG;6.25MG 005 A077302

7.5MG;7.5MG;7.5MG;7.5MG 006 A077302

May 22, 2002

Jun 22, 2012

Jun 22, 2012

Jun 22, 2012

Jun 22, 2012

Jun 22, 2012

Jun 22, 2012

Jun

Jun

Jun

Jun

Jun

Jun

Jun

CFTG

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AMPHETAMINE SULFATE

TABLET; ORAL AMPHETAMINE SULFATE

+

INDEPENDENCE PHARMS 5MG

10MG

A200166

A200166

001

002

Aug 09, 2012

Aug 09, 2012

Jul

Jul

NEWA

NEWA

AMPHOTERICIN B

INJECTABLE, LIPID COMPLEX; INJECTION AMPHOTEC

+

+

ALKOPHARMA USA 50MG/VIAL

100MG/VIAL

N050729

N050729

001

002

Nov 22, 1996

Nov 22, 1996

May

May

CAHN

CAHN

AMPICILLIN SODIUM

INJECTABLE; INJECTION AMPICILLIN SODIUM

AP

AP

AP

AP

ANTIBIIOTICE

@ HIKMA MAPLE

@

@

@

@

@

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 125MG BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

A090354

A090354

A090354

A090354

A062692

A062692

A062692

A062692

A062692

A062692

001

002

003

004

001

002

003

004

005

006

Dec 28, 2009

Dec 28, 2009

Dec 28, 2009

Dec 28, 2009

Jun 24, 1986

Jun 24, 1986

Jun 24, 1986

Jun 24, 1986

Jun 24, 1986

Jun 24, 1986

Aug

Aug

Aug

Aug

Oct

Oct

Oct

Oct

Oct

Oct

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE; INJECTION AMPICILLIN AND SULBACTAM

AP

AP

AP

HIKMA MAPLE EQ 1GM BASE/VIAL;EQ 500MG BASE/VIALEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

A065074

A065074

A065076

001

002

001

Mar 19, 2002

Mar 19, 2002

Mar 19, 2002

Oct

Oct

Oct

CAHN

CAHN

CAHN

ANAGRELIDE HYDROCHLORIDE

CAPSULE; ORAL AGRYLIN

AB SHIRE LLC EQ 0.5MG BASE

ANAGRELIDE HYDROCHLORIDE

N020333 001 Mar 14, 1997 Jan CAHN

AB

AB

MYLAN PHARMS INC

@ SANDOZ INC

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

A077613

A077613

A076683

001

002

001

Jun 27, 2006

Jun 27, 2006

Apr 18, 2005

Sep

Sep

Mar

CAHN

CAHN

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 18: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-9

CAPSULE; ORAL ANAGRELIDE HYDROCHLORIDE @ SANDOZ INC EQ 1MG BASE A076683 002 Apr 18, 2005 Mar DISC

ANASTROZOLE

TABLET; ORAL ANASTROZOLE

AB APOTEX INC 1MG A200654 001 May 11, 2012 Apr NEWA

AB IMPAX LABS INC 1MG A091242 001 May 31, 2012 May NEWA

APREPITANT

CAPSULE; ORAL APREPITANT

AB SANDOZ 40MG A090999 001 Sep 24, 2012 Sep NEWA

AB 80MG A090999 002 Sep 24, 2012 Sep NEWA

AB 125MG A090999 003 Sep 24, 2012 Sep NEWA

EMEND AB MERCK 40MG N021549 003 Jun 30, 2006 Sep CFTG

AB 80MG N021549 001 Mar 26, 2003 Sep CFTG

AB + 125MG N021549 002 Mar 26, 2003 Sep CFTG

APROTININ

INJECTABLE; INJECTION TRASYLOL @ BAYER HLTHCARE 10,000KIU/ML N020304 001 Dec 29, 1993 May DISC

ARGATROBAN

INJECTABLE; INJECTION ACOVA

AP + PFIZER 250MG/2.5ML (100MG/ML) N020883 001 Jun 30, 2000 Jan CTNA

ARGATROBAN AP HIKMA PHARM CO LTD 250MG/2.5ML (100MG/ML) N203049 001 Jan 05, 2012 Jan NEWA

ARMODAFINIL

TABLET; ORAL ARMODAFINIL

AB MYLAN PHARMS INC 50MG A200043 001 Jun 01, 2012 May NEWA

AB 150MG A200043 002 Jun 01, 2012 May NEWA

AB 250MG A200043 003 Jun 01, 2012 May NEWA

WATSON LABS INC 100MG A200156 002 Aug 29, 2012 Aug NEWA

200MG A200156 004 Aug 29, 2012 Aug NEWA

NUVIGIL AB CEPHALON 50MG N021875 001 Jun 15, 2007 May CFTG

AB 150MG N021875 003 Jun 15, 2007 May CFTG

AB + 250MG N021875 004 Jun 15, 2007 May CFTG

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

FOR SOLUTION; ORAL ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

>D> AA NOVEL LABS INC 4.7GM;100GM;1.015GM;5.9MG;2.691GM A090145 001 Jan 25, 2012 Nov CPOT ;7.5GM

>A> AA 4.7GM;100GM;1.015GM;5.9GM;2.691GM A090145 001 Jan 25, 2012 Nov CPOT ;7.5GM

AA 4.7GM;100GM;1.015GM;5.9MG;2.691GM A090145 001 Jan 25, 2012 Jan NEWA ;7.5GM

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 19: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-10

FOR SOLUTION; ORAL MOVIPREP

AA + SALIX PHARMS 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

N021881 001 Aug 02, 2006 Jan CFTG

ASENAPINE MALEATE

TABLET; SUBLINGUAL SAPHRIS

+

ORGANON SUB MERCK EQ 5MG BASE

EQ 10MG BASE

N022117

N022117

001

002

Aug 13, 2009

Aug 13, 2009

Jul

Jul

CAHN

CAHN

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE @ VINTAGE PHARMS LLC 325MG;50MG;40MG;30MG A075351 001 Mar 05, 1999 Sep CAHN

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET; ORAL INVAGESIC @ SANDOZ

INVAGESIC FORTE

385MG;30MG;25MG A074817 001 Nov 27, 1996 Oct DISC

@ SANDOZ 770MG;60MG;50MG A074817 002 Nov 27, 1996 Oct DISC

ASPIRIN; CARISOPRODOL

TABLET; ORAL CARISOPRODOL AND ASPIRIN

AB PROSAM LABS 325MG;200MG A040252 001 Dec 10, 1997 Feb CAHN

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

AB

TABLET; ORAL CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

PROSAM LABS 325MG;200MG;16MG A040283 001 Dec 29, 1998 Feb CAHN

ATOMOXETINE HYDROCHLORIDE

CAPSULE; ORAL ATOMOXETINE HYDROCHLORIDE @ ZYDUS PHARMS USA INC

@

@

@

@

@

STRATTERA

18MG

25MG

40MG

60MG

80MG

100MG

A079017

A079017

A079017

A079017

A079017

A079017

001

002

003

004

005

006

Sep 17, 2010

Sep 17, 2010

Sep 17, 2010

Sep 17, 2010

Sep 17, 2010

Sep 17, 2010

Jun

Jun

Jun

Jun

Jun

Jun

DISC

DISC

DISC

DISC

DISC

DISC

+

LILLY 10MG

18MG

25MG

40MG

60MG

80MG

100MG

N021411

N021411

N021411

N021411

N021411

N021411

N021411

002

003

004

005

006

007

008

Nov 26, 2002

Nov 26, 2002

Nov 26, 2002

Nov 26, 2002

Nov 26, 2002

Feb 14, 2005

Feb 14, 2005

Jun

Jun

Jun

Jun

Jun

Jun

Jun

CTEC

CTEC

CTEC

CTEC

CTEC

CTEC

CTEC

ATORVASTATIN CALCIUM

TABLET; ORAL ATORVASTATIN CALCIUM

AB

AB

APOTEX INC EQ 10MG BASE

EQ 20MG BASE

A090548

A090548

001

002

May 29, 2012

May 29, 2012

May

May

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 20: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-11

TABLET; ORAL ATORVASTATIN CALCIUM

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

APOTEX INC

DR REDDYS LABS LTD

MYLAN PHARMS INC

SANDOZ INC

TEVA PHARMS

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 10MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 20MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 40MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 80MG BASE

EQ 80MG BASE

A090548

A090548

A091650

A091650

A091650

A202357

A091226

A091226

A091226

A091226

A077575

A077575

A077575

A077575

A078773

A078773

A078773

A078773

A078773

A078773

A078773

A078773

A078773

A078773

A078773

A078773

003

004

001

002

003

001

001

002

003

004

001

002

003

004

001

001

001

002

002

002

003

003

003

004

004

004

May 29, 2012

May 29, 2012

Jul 17, 2012

Jul 17, 2012

Jul 17, 2012

Jul 17, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May 29, 2012

May

May

Jul

Jul

Jul

Jul

May

May

May

May

May

May

May

May

Nov

Nov

May

Nov

Nov

May

Nov

Nov

May

Nov

Nov

May

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

DISC

DISC

NEWA

DISC

DISC

NEWA

DISC

DISC

NEWA

DISC

DISC

NEWA

ATRACURIUM BESYLATE

INJECTABLE; INJECTION ATRACURIUM BESYLATE

AP

AP

AP

+ BEDFORD 10MG/ML

HOSPIRA INC 10MG/ML

SAGENT PHARMS 10MG/ML

ATRACURIUM BESYLATE PRESERVATIVE FREE

A074901

A090761

A091489

001

001

001

Jul 18, 1997

Oct 18, 2012

Feb 17, 2012

Feb

Oct

Feb

CTEC

NEWA

NEWA

AP

AP

AP

+ BEDFORD

HOSPIRA INC

SAGENT PHARMS

10MG/ML

10MG/ML

10MG/ML

A074900

A090782

A091488

001

001

001

Jul 18, 1997

Oct 18, 2012

Feb 17, 2012

Feb

Oct

Feb

CTEC

NEWA

NEWA

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

SOLUTION; ORAL DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

AA + ROXANE

LOMOTIL

0.025MG/5ML;2.5MG/5ML A087708 001 May 03, 1982 Apr CRLD

@ GD SEARLE LLC 0.025MG/5ML;2.5MG/5ML N012699 001 Apr DISC

AVANAFIL

TABLET; ORAL STENDRA

+

VIVUS 50MG

100MG

200MG

N202276

N202276

N202276

001

002

003

Apr 27, 2012

Apr 27, 2012

Apr 27, 2012

Apr

Apr

Apr

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 21: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-12

AXITINIB

TABLET; ORAL INLYTA

PFIZER

+

1MG

5MG

N202324

N202324

001

002

Jan 27, 2012

Jan 27, 2012

Jan

Jan

NEWA

NEWA

AZELAIC ACID

GEL; TOPICAL FINACEA

+ BAYER HLTHCARE 15% N021470 001 Dec 24, 2002 Jun CAHN

AZELASTINE HYDROCHLORIDE

AT

AB

AB

AB

SOLUTION/DROPS; OPHTHALMICAZELASTINE HYDROCHLORIDE

ALCON PHARMA 0.05%

SPRAY, METERED; NASAL ASTEPRO

+ MEDA PHARMS EQ 0.1876MG BASE/SPRAY

AZELASTINE HYDROCHLORIDE APOTEX INC EQ 0.1876MG BASE/SPRAY

SUN PHARMA GLOBAL EQ 0.125MG BASE/SPRAY

A202305

N022371

A201846

A090423

001

001

001

001

May 31, 2012

Aug 31, 2009

Aug 31, 2012

May 23, 2012

May

Aug

Aug

May

NEWA

CFTG

NEWA

NEWA

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

SPRAY, METERED; NASAL DYMISTA

+ MEDA PHARMS EQ 0.125MGBASE/SPRAY;0.05MG/SPRAY

N202236 001 May 01, 2012 May NEWA

AZILSARTAN KAMEDOXOMIL

TABLET; ORAL EDARBI

TAKEDA PHARMS USA

+

EQ 40MG MEDOXOMIL

EQ 80MG MEDOXOMIL

N200796

N200796

001

002

Feb 25, 2011

Feb 25, 2011

Apr

Apr

CAHN

CAHN

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

TABLET; ORAL EDARBYCLOR

TAKEDA PHARMS USA EQ 40MG MEDOXOMIL;12.5MG

+ EQ 40MG MEDOXOMIL;25MG

N202331

N202331

001

002

Dec 20, 2011

Dec 20, 2011

Apr

Apr

CAHN

CAHN

AZITHROMYCIN

FOR SUSPENSION; ORAL AZITHROMYCIN @ SANDOZ

@

INJECTABLE; INJECTION AZITHROMYCIN @ PLIVA HRVATSKA DOO

@ TEVA PARENTERAL

@

EQ 100MG BASE/5ML

EQ 200MG BASE/5ML

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 2.5GM BASE/VIAL

A065297

A065297

A065265

N050809

N050809

001

002

001

001

002

Sep 18, 2006

Sep 18, 2006

Jan 18, 2007

Dec 19, 2006

Dec 19, 2006

Oct

Oct

Jul

Jun

Jun

DISC

DISC

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 22: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-13

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

AT

AT

OINTMENT; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

AKORN 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

001 A065213

+ BAUSCH AND LOMB 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

001 A064068

Jul 25, 2012

Oct 30, 1995

Jul

Jul

NEWA

CTEC

BACLOFEN

INJECTABLE; INTRATHECAL GABLOFEN

CNS THERAPS INC

TABLET; ORAL BACLOFEN

1MG/ML N022462 004 Jun 22, 2012 Jun NEWA

AB

AB

AB

AB

MYLAN PHARMS INC 10MG

20MG

PROSAM LABS 10MG

20MG

TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO

A090334

A090334

A077089

A077088

001

002

001

001

Feb 18, 2010

Feb 18, 2010

Oct 31, 2007

Oct 31, 2007

Sep

Sep

Feb

Feb

CAHN

CAHN

CAHN

CAHN

@ UCB INC

@

10MG

20MG

N021589

N021589

001

002

Oct 30, 2003

Oct 30, 2003

Jan

Jan

CAHN

CAHN

BALSALAZIDE DISODIUM

TABLET; ORAL GIAZO

+ SALIX PHARMS 1.1GM N022205 001 Feb 03, 2012 Feb NEWA

BECLOMETHASONE DIPROPIONATE

AEROSOL, METERED; NASAL QNASL

+ TEVA BRANDED PHARM

+

0.08MG/ACTUATION

0.08MG/ACTIVATION

N202813

N202813

001

001

Mar 23, 2012

Mar 23, 2012

Sep

Mar

CPOT

NEWA

BENAZEPRIL HYDROCHLORIDE

TABLET; ORAL LOTENSIN

AB

AB

AB

AB +

US PHARMS HOLDINGS I 5MG

10MG

20MG

40MG

N019851

N019851

N019851

N019851

001

002

003

004

Jun 25, 1991

Jun 25, 1991

Jun 25, 1991

Jun 25, 1991

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE @ MYLAN PHARMS INC

@

@

@

LOTENSIN HCT

5MG;6.25MG

10MG;12.5MG

20MG;12.5MG

20MG;25MG

A076612

A076612

A076612

A076612

001

002

003

004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Oct

Oct

Oct

Oct

DISC

DISC

DISC

DISC

AB

AB

AB

AB +

US PHARMS HOLDINGS I 5MG;6.25MG

10MG;12.5MG

20MG;12.5MG

20MG;25MG

N020033

N020033

N020033

N020033

001

002

004

003

May 19, 1992

May 19, 1992

May 19, 1992

May 19, 1992

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 23: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-14

BENZONATATE

CAPSULE; ORAL BENZONATATE @ NESHER PHARMS

@

100MG

200MG

A040795

A040795

001

002

Oct 31, 2007

Oct 31, 2007

Jun

Jun

DISC

DISC

AB

BT

AB

AB

AB

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL; TOPICAL BENZACLIN

VALEANT INTL 5%;EQ 1% BASE

+ 5%;EQ 1% BASE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE MYLAN PHARMS INC 5%;EQ 1% BASE

PERRIGO ISRAEL 5%;1.2%

DUAC + STIEFEL 5%;1.2%

N050756

N050756

A065443

A090979

N050741

001

002

001

001

001

Dec 21, 2000

Apr 20, 2007

Aug 11, 2009

Jun 26, 2012

Aug 26, 2002

Apr

Apr

Sep

Jun

Jun

CAHN

CAHN

CAHN

NEWA

CFTG

AB

BENZOYL PEROXIDE; ERYTHROMYCIN

GEL; TOPICAL BENZAMYCIN

+ VALEANT INTL 5%;3%

BENZAMYCIN PAK + VALEANT INTL 5%;3%

N050557

N050769

001

001

Oct 26, 1984

Nov 27, 2000

Jan

Jun

CAHN

CAHN

BENZPHETAMINE HYDROCHLORIDE

AA

TABLET; ORAL BENZPHETAMINE HYDROCHLORIDE

EMCURE PHARMS LTD 50MG A202061 001 Jan 27, 2012 Jan NEWA

BENZTROPINE MESYLATE

>A>

>A>

>A>

AP

AP

AA

AA

AA

AA

AA

AA

AA

AA

AA

INJECTABLE; INJECTION BENZTROPINE MESYLATE

APP PHARMS LLC

COGENTIN + OAK PHARMS AKORN

TABLET; ORAL BENZTROPINE MESYLATE

EXCELLIUM

@ LANNETT HOLDINGS INC

@

@

PROSAM LABS

+ USL PHARMA

+

+

1MG/ML

1MG/ML

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

A090233

N012015

A090168

A090168

A090168

A088877

A088894

A088895

A040699

A040705

A040706

A040103

A040103

A040103

001

001

001

002

003

001

001

001

001

001

001

001

002

003

Jul 28, 2009

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Apr 11, 1985

Apr 11, 1985

Apr 11, 1985

Feb 14, 2008

Feb 14, 2008

Feb 14, 2008

Dec 12, 1996

Dec 12, 1996

Dec 12, 1996

May

Feb

Nov

Nov

Nov

Jan

Jan

Jan

Feb

Feb

Feb

Jan

Jan

Jan

CAHN

CAHN

NEWA

NEWA

NEWA

DISC

DISC

DISC

CMFD

CMFD

CMFD

CRLD

CRLD

CRLD

BETAMETHASONE

SYRUP; ORAL CELESTONE @ SCHERING 0.6MG/5ML N014215 002 May DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 24: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-15

BETAMETHASONE DIPROPIONATE

AB

AB

AB

AB

AB

CREAM; TOPICAL BETAMETHASONE DIPROPIONATE

+ FOUGERA PHARMS EQ 0.05% BASE

CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE

FOUGERA PHARMS EQ 0.05% BASE

GEL, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE

+ FOUGERA PHARMS EQ 0.05% BASE

LOTION, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE

FOUGERA PHARMS EQ 0.05% BASE

OINTMENT, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE

FOUGERA PHARMS EQ 0.05% BASE

N019137

A076215

A075276

A077111

A075373

001

001

001

001

001

Jun 26, 1984

Dec 09, 2003

May 13, 2003

May 21, 2007

Jun 22, 1999

Jan

Jan

Jan

Jan

Jan

CAHN

CAHN

CAHN

CAHN

CAHN

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

SUSPENSION; TOPICAL TACLONEX

+ LEO PHARM 0.064%;0.005% N022185 001 May 09, 2008 Oct CTNA

AB

AB

AB

AB

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

CREAM; TOPICAL CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

FOUGERA PHARMS EQ 0.05% BASE;1%

LOTRISONE + MERCK SHARP DOHME EQ 0.05% BASE;1%

LOTION; TOPICAL CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

FOUGERA PHARMS EQ 0.05% BASE;1%

LOTRISONE + SCHERING CORP EQ 0.05% BASE;1%

A075502

N018827

A076516

N020010

001

001

001

001

Jun 05, 2001

Jul 10, 1984

Jun 16, 2005

Dec 08, 2000

Jan

Oct

Jan

Feb

CAHN

CAHN

CAHN

CAHN

BETAMETHASONE VALERATE

>A> >A>

>D>

>A>

AB

AB

AEROSOL, FOAM; TOPICAL BETAMETHASONE VALERATE

PERRIGO

LUXIQ + STIEFEL

+

+

EQ 0.12% BASE

EQ 0.12% BASE

EQ 0.12% BASE

EQ 0.12% BASE

A078337

N020934

N020934

N020934

001

001

001

001

Nov 26, 2012

Feb 28, 1999

Feb 28, 1999

Feb 28, 1999

Nov

Nov

Nov

Jan

NEWA

CFTG

CFTG

CAHN

BISOPROLOL FUMARATE

AB

AB

TABLET; ORAL ZEBETA

TEVA WOMENS

+

5MG

10MG

N019982

N019982

002

001

Jul 31, 1992

Jul 31, 1992

Jan

Jan

CAHN

CAHN

BOCEPREVIR

CAPSULE; ORAL VICTRELIS

+ MERCK SHARP DOHME 200MG N202258 001 May 13, 2011 Mar CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 25: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-16

BORTEZOMIB

INJECTABLE; INTRAVENOUS, SUBCUTANEOUS VELCADE

+ MILLENNIUM PHARMS 3.5MG/VIAL N021602 001 May 13, 2003 Jan CDFR

BOSENTAN

TABLET; ORAL TRACLEER

ACTELION PHARMS LTD

+

62.5MG

125MG

N021290

N021290

001

002

Nov 20, 2001

Nov 20, 2001

May

May

CAHN

CAHN

BOSUTINIB MONOHYDRATE

TABLET; ORAL BOSULIF

WYETH PHARMS INC

+

EQ 100MG BASE

EQ 500MG BASE

N203341

N203341

001

002

Sep 04, 2012

Sep 04, 2012

Sep

Sep

NEWA

NEWA

BRETYLIUM TOSYLATE

INJECTABLE; INJECTION BRETYLIUM TOSYLATE @ HIKMA MAPLE

@

50MG/ML

50MG/ML

A070545

A070546

001

001

May 14, 1986

May 14, 1986

Oct

Oct

CAHN

CAHN

BROMOCRIPTINE MESYLATE

AB

AB

CAPSULE; ORAL PARLODEL

+ US PHARMS HOLDINGS I

TABLET; ORAL PARLODEL

+ US PHARMS HOLDINGS I

EQ 5MG BASE

EQ 2.5MG BASE

N017962

N017962

002

001

Mar 01, 1982 Sep

Sep

CAHN

CAHN

BUDESONIDE

AN

AN

AN

AN

POWDER, METERED; INHALATION PULMICORT @ ASTRAZENECA 0.16MG/INH

SUSPENSION; INHALATION BUDESONIDE

TEVA PHARMS 0.25MG/2ML

0.5MG/2ML

WATSON LABS INC 0.25MG/2ML

0.5MG/2ML

N020441

A077519

A077519

A078404

A078404

002

001

002

001

002

Jun 24, 1997

Nov 18, 2008

Nov 18, 2008

Jul 31, 2012

Jul 31, 2012

Jun

Sep

Sep

Jul

Jul

DISC

CAHN

CAHN

NEWA

NEWA

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

AEROSOL, METERED; INHALATION SYMBICORT

+ ASTRAZENECA 0.08MG/INH;0.0045MG/INH

+ 0.16MG/INH;0.0045MG/INH

N021929

N021929

001

002

Jul 21, 2006

Jul 21, 2006

Jan

Jan

CDFR

CDFR

BUMETANIDE

AP

INJECTABLE; INJECTION BUMETANIDE

HIKMA MAPLE 0.25MG/ML A079196 001 Apr 30, 2008 Oct CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 26: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-17

BUPIVACAINE

INJECTABLE, LIPOSOMAL; INJECTION EXPAREL @ PACIRA PHARMS INC 133MG/10ML (13.3MG/ML) N022496 001 Oct 28, 2011 Jul DISC

BUPRENORPHINE HYDROCHLORIDE

TABLET; SUBLINGUAL BUPRENORPHINE HYDROCHLORIDE

AB + ROXANE

SUBUTEX

EQ 8MG BASE A078633 002 Oct 08, 2009 Aug CRLD

@ RECKITT BENCKISER

@

EQ 2MG BASE

EQ 8MG BASE

N020732

N020732

002

003

Oct 08, 2002

Oct 08, 2002

Aug

Aug

DISC

DISC

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FILM; SUBLINGUAL SUBOXONE

RECKITT BENCKISER

+

TABLET; SUBLINGUAL SUBOXONE

EQ 2MG BASE;EQ 0.5MG BASE

EQ 4MG BASE;EQ 1MG BASE

EQ 8MG BASE;EQ 2MG BASE

EQ 12MG BASE;EQ 3MG BASE

N022410

N022410

N022410

N022410

001

003

002

004

Aug 30, 2010

Aug 10, 2012

Aug 30, 2010

Aug 10, 2012

Apr

Aug

Apr

Aug

CAIN

NEWA

CAIN

NEWA

+

RECKITT BENCKISER EQ 2MG BASE;EQ 0.5MG BASE

EQ 8MG BASE;EQ 2MG BASE

N020733

N020733

001

002

Oct 08, 2002

Oct 08, 2002

Apr

Apr

CPOT

CPOT

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL BUPROPION HYDROCHLORIDE

>A>

BX

AB1

AB3

AB1

AB1

IMPAX LABS

WOCKHARDT LTD

FORFIVO XL

300MG

100MG

150MG

150MG

200MG

A077415

A201331

A202189

A201331

A201331

002

001

001

002

003

Dec 15, 2006

Aug 30, 2012

Nov 21, 2012

Aug 30, 2012

Aug 30, 2012

Sep

Aug

Nov

Aug

Aug

CTEC

NEWA

NEWA

NEWA

NEWA

+ EDGEMONT PHARMS LLC

WELLBUTRIN SR

450MG N022497 001 Nov 10, 2011 Mar CAHN

AB1

AB1 +

GLAXOSMITHKLINE

WELLBUTRIN XL

150MG

200MG

N020358

N020358

003

004

Oct 04, 1996

Jun 14, 2002

Sep

Sep

CRLD

CRLD

AB3

AB3 +

VALEANT INTL 150MG

300MG

N021515

N021515

001

002

Aug 28, 2003

Aug 28, 2003

Sep

Sep

CRLD

CRLD

BUSPIRONE HYDROCHLORIDE

TABLET; ORAL BUSPIRONE HYDROCHLORIDE @ APOTEX

@

@

@ EGIS

@

@

@ NESHER PHARMS

@

@

@ PROSAM LABS

5MG

10MG

15MG

5MG

10MG

15MG

5MG

10MG

15MG

5MG

A075521

A075521

A075521

A075119

A075119

A075119

A075572

A075572

A075572

A075388

001

002

003

001

002

003

001

002

003

001

Apr 05, 2002

Apr 05, 2002

Apr 05, 2002

Mar 14, 2002

Mar 14, 2002

Jan 23, 2003

Feb 27, 2002

Feb 27, 2002

Feb 27, 2002

May 09, 2002

Mar

Mar

Mar

Mar

Mar

Mar

Jun

Jun

Jun

Mar

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 27: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-18

TABLET; ORAL BUSPIRONE HYDROCHLORIDE

AB

AB

AB

AB

@

@

PROSAM LABS 5MG

10MG

10MG

15MG

15MG

30MG

A075388

A075388

A075388

A075388

A075388

A078302

001

002

002

003

003

001

May 09, 2002

May 09, 2002

May 09, 2002

May 09, 2002

May 09, 2002

Dec 17, 2007

Feb

Mar

Feb

Mar

Feb

Feb

CMFD

DISC

CMFD

DISC

CMFD

CMFD

BUTOCONAZOLE NITRATE

CREAM; VAGINAL BUTOCONAZOLE NITRATE

>D>

>A> AB

@ PERRIGO ISRAEL

@

GYNAZOLE-1

2%

2%

2%

A200923

A200923

A200923

001

001

001

May 18, 2012

May 18, 2012

May 18, 2012

Nov

Nov

Apr

CMFD

CMFD

NEWA

>D>

>A> AB

+

+

KV PHARM 2%

2%

N019881

N019881

001

001

Feb 07, 1997

Feb 07, 1997

Nov

Nov

CTEC

CTEC

>A> CABOZANTINIB S-MALATE

>A> >A> >A>

>A>

CAPSULE; ORAL COMETRIQ

EXELIXIS

+

EQ 20MG BASE

EQ 80MG BASE

N203756

N203756

001

002

Nov 29, 2012

Nov 29, 2012

Nov

Nov

NEWA

NEWA

CAFFEINE CITRATE

SOLUTION; INTRAVENOUS CAFCIT

AP + BEDFORD LABS

CAFFEINE CITRATE

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N020793 001 Sep 21, 1999 Jan CAHN

AP SAGENT PHARMS

SOLUTION; ORAL CAFCIT

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

A090827 001 Aug 29, 2012 Aug NEWA

AA + BEDFORD LABS

CAFFEINE CITRATE

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N020793 002 Apr 12, 2000 Jan CAHN

AA SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

A091102 001 Aug 29, 2012 Aug NEWA

CALCIPOTRIENE

CREAM; TOPICAL CALCIPOTRIENE

AB TOLMAR

DOVONEX

0.005% A200935 001 May 30, 2012 May NEWA

AB + LEO PHARMA AS

SOLUTION; TOPICAL CALCIPOTRIENE

0.005% N020554 001 Jul 22, 1996 May CFTG

AT FOUGERA PHARMS 0.005% A078305 001 May 06, 2008 Jan CAHN

CALCIUM ACETATE

CAPSULE; ORAL CALCIUM ACETATE

AB PADDOCK LLC EQ 169MG CALCIUM A091312 001 Jun 01, 2012 May NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 28: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-19

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION; IRRIGATION LACTATED RINGER'S IN PLASTIC CONTAINER

AT

AT

AT

AT

+

+

+

+

B BRAUN

BAXTER HLTHCARE

HOSPIRA

20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

N018681

N019933

N018921

N019416

001

001

001

001

Dec 27, 1982

Aug 29, 1989

Apr 03, 1984

Jan 17, 1986

Oct

Oct

Oct

Oct

CRLD

CRLD

CRLD

CRLD

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET; ORAL ATACAND HCT

>D>

>A>

>D>

>A>

>D>

>A>

>A>

AB

AB

AB

+

+

ASTRAZENECA 16MG;12.5MG

16MG;12.5MG

32MG;12.5MG

32MG;12.5MG

32MG;25MG

32MG;25MG

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

N021093

N021093

N021093

N021093

N021093

N021093

001

001

002

002

003

003

Sep 05, 2000

Sep 05, 2000

Sep 05, 2000

Sep 05, 2000

May 16, 2008

May 16, 2008

Nov

Nov

Nov

Nov

Nov

Nov

CFTG

CFTG

CFTG

CFTG

CFTG

CFTG

>A>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

APOTEX INC

MYLAN LABS

16MG;12.5MG

32MG;12.5MG

16MG;12.5MG

32MG;12.5MG

32MG;25MG

A202884

A202884

A090704

A090704

A090704

001

002

001

002

003

Dec 04, 2012

Dec 04, 2012

Dec 04, 2012

Dec 04, 2012

Dec 04, 2012

Nov

Nov

Nov

Nov

Nov

NEWA

NEWA

NEWA

NEWA

NEWA

CAPTOPRIL

TABLET; ORAL CAPTOPRIL @ VINTAGE PHARMS LLC

@

@

@

12.5MG

25MG

50MG

100MG

A074418

A074418

A074418

A074418

001

002

003

004

Feb 13, 1996

Feb 13, 1996

Feb 13, 1996

Feb 13, 1996

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

CAPTOPRIL; HYDROCHLOROTHIAZIDE

TABLET; ORAL CAPTOPRIL AND HYDROCHLOROTHIAZIDE @ VINTAGE PHARMS LLC

@

@

@

25MG;15MG

25MG;25MG

50MG;15MG

50MG;25MG

A074788

A074788

A074788

A074788

001

002

004

003

Dec 29, 1997

Dec 29, 1997

Dec 29, 1997

Dec 29, 1997

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

CARBAMAZEPINE

CAPSULE, EXTENDED RELEASE; ORAL CARBAMAZEPINE

AB

AB

AB

TEVA PHARMS 100MG

200MG

300MG

A078592

A078592

A078592

001

002

003

Sep 20, 2012

Sep 20, 2012

Sep 20, 2012

Sep

Sep

Sep

NEWA

NEWA

NEWA

CARBIDOPA; ENTACAPONE; LEVODOPA

AB

AB

TABLET; ORAL CARBIDOPA, LEVODOPA AND ENTACAPONE

SUN PHARMA GLOBAL 25MG;200MG;100MG

37.5MG;200MG;150MG

A079085

A079085

001

002

May 10, 2012

May 10, 2012

Apr

Apr

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 29: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-20

TABLET; ORAL CARBIDOPA, LEVODOPA AND ENTACAPONE

>A> AB WOCKHARDT LTD 12.5MG;200MG;50MG A090786 001 Nov 20, 2012 Nov NEWA

>A> AB 18.75MG;200MG;75MG A090833 001 Nov 20, 2012 Nov NEWA

>A> AB 25MG;200MG;100MG A090833 002 Nov 20, 2012 Nov NEWA

>A> AB 31.25MG;200MG;125MG A090833 003 Nov 20, 2012 Nov NEWA

>A> AB 37.5MG;200MG;150MG A090833 004 Nov 20, 2012 Nov NEWA

>A> AB 50MG;200MG;200MG A090833 005 Nov 20, 2012 Nov NEWA

STALEVO 100 AB ORION PHARMA 25MG;200MG;100MG N021485 002 Jun 11, 2003 Apr CFTG

STALEVO 125 >D>

>A> AB

ORION PHARMA 31.25MG;200MG;125MG

31.25MG;200MG;125MG

N021485

N021485

006

006

Aug 29, 2008

Aug 29, 2008

Nov

Nov

CFTG

CFTG

STALEVO 150 AB ORION PHARMA 37.5MG;200MG;150MG N021485 003 Jun 11, 2003 Apr CFTG

STALEVO 200 >D> + ORION PHARMA 50MG;200MG;200MG N021485 004 Aug 02, 2007 Nov CFTG

>A> AB + 50MG;200MG;200MG N021485 004 Aug 02, 2007 Nov CFTG

STALEVO 50 >D> + ORION PHARMA 12.5MG;200MG;50MG N021485 001 Jun 11, 2003 Nov CFTG

>A> AB + 12.5MG;200MG;50MG N021485 001 Jun 11, 2003 Nov CFTG

STALEVO 75 >D>

>A> AB

ORION PHARMA 18.75MG;200MG;75MG

18.75MG;200MG;75MG

N021485

N021485

005

005

Aug 29, 2008

Aug 29, 2008

Nov

Nov

CFTG

CFTG

CARBIDOPA; LEVODOPA

TABLET, ORALLY DISINTEGRATING; ORAL PARCOPA

AB UCB INC 10MG;100MG A076699 001 Aug 27, 2004 Jan CAHN

AB

AB

25MG;100MG

+ 25MG;250MG

A076699

A076699

002

003

Aug 27, 2004

Aug 27, 2004

Jan

Jan

CAHN

CAHN

CARBOPLATIN

INJECTABLE; INJECTION CARBOPLATIN

AP CIPLA LTD 50MG/VIAL A077383 001 Jan 27, 2006 Mar CAHN

AP 150MG/VIAL A077383 002 Jan 27, 2006 Mar CAHN

AP 450MG/VIAL A077383 003 Jan 27, 2006 Mar CAHN

AP ONCO THERAPIES LTD 50MG/VIAL A091510 001 May 29, 2012 May NEWA

AP

AP

150MG/VIAL

450MG/VIAL

A091510

A091510

002

003

May 29, 2012

May 29, 2012

May

May

NEWA

NEWA

PARAPLATIN @ CORDEN PHARMA 50MG/VIAL N019880 001 Mar 03, 1989 Feb CAHN

@ 150MG/VIAL N019880 002 Mar 03, 1989 Feb CAHN

@ 450MG/VIAL N019880 003 Mar 03, 1989 Feb CAHN

INJECTABLE; IV (INFUSION)CARBOPLATIN

AP ACTAVIS TOTOWA 50MG/5ML (10MG/ML) A078732 001 Feb 06, 2012 Jan NEWA

AP 150MG/15ML (10MG/ML) A078732 002 Feb 06, 2012 Jan NEWA

AP 450MG/45ML (10MG/ML) A078732 003 Feb 06, 2012 Jan NEWA

AP

AP

600MG/60ML (10MG/ML)

CIPLA LTD 50MG/5ML (10MG/ML)

A078732

A077861

004

001

Feb 06, 2012

Jan 18, 2007

Jan

Mar

NEWA

CAHN

AP 150MG/15ML (10MG/ML) A077861 002 Jan 18, 2007 Mar CAHN

AP 450MG/45ML (10MG/ML) A077861 003 Jan 18, 2007 Mar CAHN

AP 600MG/60ML (10MG/ML) A077861 004 Jan 18, 2007 Mar CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 30: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-21

CARFILZOMIB

POWDER; INTRAVENOUS KYPROLIS

+ ONYX PHARMS 60MG/VIAL N202714 001 Jul 20, 2012 Jul NEWA

CARISOPRODOL

AA

TABLET; ORAL CARISOPRODOL

PROSAM LABS 350MG A040188 001 Mar 07, 1997 Feb CAHN

CEFACLOR

AB

AB

AB

AB

AB

AB

AB

AB

CAPSULE; ORAL CEFACLOR @ RANBAXY

@

FOR SUSPENSION; ORAL CEFACLOR @ RANBAXY

+

@

+

@

+

@

+

YUNG SHIN PHARM

TABLET, CHEWABLE; ORAL RANICLOR @ RANBAXY LABS LTD

@

@

@

EQ 250MG BASE

EQ 500MG BASE

EQ 125MG BASE/5ML

EQ 125MG BASE/5ML

EQ 187MG BASE/5ML

EQ 187MG BASE/5ML

EQ 250MG BASE/5ML

EQ 250MG BASE/5ML

EQ 375MG BASE/5ML

EQ 375MG BASE/5ML

EQ 125MG BASE/5ML

EQ 187MG BASE/5ML

EQ 250MG BASE/5ML

EQ 375MG BASE/5ML

EQ 125MG BASE

EQ 187MG BASE

EQ 250MG BASE

EQ 375MG BASE

A064156

A064156

A064166

A064166

A064165

A064165

A064164

A064164

A064155

A064155

A065412

A065412

A065412

A065412

A065092

A065092

A065092

A065092

001

002

001

001

001

001

001

001

001

001

001

002

003

004

001

002

003

004

Aug 28, 1997

Aug 28, 1997

Oct 02, 1997

Oct 02, 1997

Oct 02, 1997

Oct 02, 1997

Oct 02, 1997

Oct 02, 1997

Oct 02, 1997

Oct 02, 1997

Feb 17, 2012

Feb 17, 2012

Feb 17, 2012

Feb 17, 2012

Dec 22, 2003

Dec 22, 2003

Dec 22, 2003

Dec 22, 2003

Apr

Apr

Apr

Feb

Apr

Feb

Apr

Feb

Apr

Feb

Feb

Feb

Feb

Feb

Apr

Apr

Apr

Apr

DISC

DISC

DISC

CTEC

DISC

CTEC

DISC

CTEC

DISC

CTEC

NEWA

NEWA

NEWA

NEWA

DISC

DISC

DISC

DISC

>A>

>A>

AB

AB

CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE; ORAL CEFADROXIL @ RANBAXY LABS LTD EQ 500MG BASE

FOR SUSPENSION; ORAL CEFADROXIL

HIKMA PHARMS EQ 250MG BASE/5ML

EQ 500MG BASE/5ML

TABLET; ORAL CEFADROXIL @ RANBAXY EQ 1GM BASE

+ TEVA PHARMS EQ 1GM BASE

A065015

A091036

A091036

A065018

A062774

001

001

002

001

001

Jun 22, 1999

Nov 28, 2012

Nov 28, 2012

Apr 23, 1999

Apr 08, 1987

Apr

Nov

Nov

Apr

Aug

DISC

NEWA

NEWA

DISC

CAHN

CEFAZOLIN SODIUM

>D> AP

INJECTABLE; INJECTION CEFAZOLIN AND DEXTROSE

B BRAUN

CEFAZOLIN SODIUM CEPHAZONE PHARMA

EQ 2GM BASE/VIAL

EQ 500MG BASE/VIAL

N050779

A065280

003

001

Jan 13, 2012

Mar 18, 2009

May

Nov

NEWA

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 31: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-22

INJECTABLE; INJECTION CEFAZOLIN SODIUM

>A>

>D>

>A>

>D>

>A>

>D>

>A>

AP

AP

AP

@ CEPHAZONE PHARMA

@

@

@

@ HIKMA MAPLE

@

@

@

@

@

@ TEVA PHARMS

@

@

@

@

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

EQ 20GM BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

A065280

A065280

A065280

A065295

A065295

A065296

A065296

A062807

A062807

A062807

A062807

A062807

A062807

A063016

A063016

A063016

A063018

A063018

001

002

002

001

001

001

001

001

002

003

004

005

006

001

002

003

001

002

Mar 18, 2009

Mar 18, 2009

Mar 18, 2009

Mar 18, 2009

Mar 18, 2009

Mar 18, 2009

Mar 18, 2009

Jan 12, 1988

Jan 12, 1988

Jan 12, 1988

Jan 12, 1988

Jan 12, 1988

Jan 12, 1988

Mar 14, 1989

Mar 14, 1989

Mar 14, 1989

Mar 05, 1990

Mar 05, 1990

Nov

Nov

Nov

Nov

Nov

Nov

Nov

Oct

Oct

Oct

Oct

Oct

Oct

Oct

Oct

Oct

Oct

Oct

DISC

DISC

DISC

DISC

DISC

DISC

DISC

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CEFDITOREN PIVOXIL

TABLET; ORAL SPECTRACEF

+

VANSEN PHARMA 200MG

400MG

N021222

N021222

001

002

Aug 29, 2001

Jul 21, 2008

Mar

Mar

CAHN

CAHN

CEFEPIME HYDROCHLORIDE

INJECTABLE; INJECTION CEFEPIME HYDROCHLORIDE

AP

AP

HOSPIRA INC EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

A202268

A202268

001

002

Jul 30, 2012

Jul 30, 2012

Jul

Jul

NEWA

NEWA

CEFIXIME

CAPSULE; ORAL SUPRAX

+ LUPIN LTD 400MG N203195 001 Jun 01, 2012 Jun NEWA

CEFOTAXIME SODIUM

INJECTABLE; INJECTION CEFOTAXIME SODIUM

>D>

>A>

AP CEPHAZONE PHARMA

@

CLAFORAN

EQ 10GM BASE/VIAL

EQ 10GM BASE/VIAL

A065348

A065348

001

001

Jan 25, 2010

Jan 25, 2010

Nov

Nov

DISC

DISC

AP

AP

+

+

SANOFI AVENTIS US EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

A062659

A062659

001

002

Jan 13, 1987

Jan 13, 1987

Mar

Mar

CRLD

CRLD

CEFOXITIN SODIUM

INJECTABLE; INJECTION CEFOXITIN

AP

AP

AP

AP

AP

AP

ANTIBIOTICOS BRASIL

HIKMA MAPLE

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

A065467

A065467

A065464

A065051

A065051

A065050

001

002

001

001

002

001

Aug 31, 2011

Aug 31, 2011

Aug 31, 2011

Sep 11, 2000

Sep 11, 2000

Sep 11, 2000

Jul

Jul

Jul

Oct

Oct

Oct

CAIN

CAIN

CAIN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 32: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-23

CEFPODOXIME PROXETIL

FOR SUSPENSION; ORAL CEFPODOXIME PROXETIL

>D>

>D>

>A>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

+

+

AUROBINDO PHARMA

AUROBINDO PHARMA LTD

SANDOZ

EQ 50MG BASE/5ML

EQ 100MG BASE/5ML

EQ 50MG BASE/5ML

EQ 100MG BASE/5ML

EQ 100MG BASE/5ML

EQ 100MG BASE/5ML

A065409

A065409

A065409

A065409

A090031

A090031

001

002

001

002

002

002

Jun 08, 2007

Jun 08, 2007

Jun 08, 2007

Jun 08, 2007

Jan 14, 2009

Jan 14, 2009

Nov

Nov

Nov

Nov

Nov

Nov

CAHN

CRLD

CAHN

CRLD

CRLD

CRLD

CEFPROZIL

FOR SUSPENSION; ORAL CEFPROZIL

AB

AB

APOTEX INC

@ RANBAXY LABS LTD

@

CEFZIL

125MG/5ML

250MG/5ML

125MG/5ML

250MG/5ML

A065351

A065351

A065202

A065202

001

002

001

002

Feb 29, 2012

Feb 29, 2012

Jun 30, 2006

Jun 30, 2006

Feb

Feb

Apr

Apr

NEWA

NEWA

DISC

DISC

>D>

>D>

>A>

>A>

@ BRISTOL MYERS SQUIBB 125MG/5ML

@ 250MG/5ML

@ CORDEN PHARMA 125MG/5ML

@ 250MG/5ML

TABLET; ORAL CEFPROZIL

N050665

N050665

N050665

N050665

001

002

001

002

Dec 23, 1991

Dec 23, 1991

Dec 23, 1991

Dec 23, 1991

Nov

Nov

Nov

Nov

CAHN

CAHN

CAHN

CAHN

@ RANBAXY LABS LTD

@

CEFZIL

250MG

500MG

A065198

A065198

001

002

Dec 13, 2006

Dec 13, 2006

Apr

Apr

DISC

DISC

@ CORDEN PHARMA

@

250MG

500MG

N050664

N050664

001

002

Dec 23, 1991

Dec 23, 1991

Feb

Feb

CAHN

CAHN

CEFTAZIDIME

INJECTABLE; INJECTION FORTAZ

AP

AP

AP

AP

+

+

+

+

COVIS PHARMA 500MG/VIAL

1GM/VIAL

2GM/VIAL

6GM/VIAL

N050578

N050578

N050578

N050578

001

002

003

004

Jul 19, 1985

Jul 19, 1985

Jul 19, 1985

Jul 19, 1985

Apr

Apr

Apr

Apr

CAHN

CAHN

CAHN

CAHN

CEFTAZIDIME SODIUM

INJECTABLE; INJECTION FORTAZ IN PLASTIC CONTAINER

+

+

@ COVIS PHARMA EQ 10MG BASE/ML

EQ 20MG BASE/ML

EQ 40MG BASE/ML

N050634

N050634

N050634

001

002

003

Apr 28, 1989

Apr 28, 1989

Apr 28, 1989

Apr

Apr

Apr

CAHN

CAHN

CAHN

CEFTRIAXONE SODIUM

INJECTABLE; IM-IV CEFTRIAXONE

>D>

>A>

>D>

AP

AP

AP

AP

AP

AP

@

AKORN INC

CEPHAZONE PHARMA

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 250MG BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

A065305

A065305

A065305

A065305

A065294

A065294

A065294

001

002

003

004

001

001

002

Jan 11, 2008

Jan 11, 2008

Jan 11, 2008

Jan 11, 2008

Mar 26, 2007

Mar 26, 2007

Mar 26, 2007

Oct

Oct

Oct

Oct

Nov

Nov

Nov

CAHN

CAHN

CAHN

CAHN

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 33: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-24

>A>

>D>

>A>

>D>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

INJECTABLE; IM-IV CEFTRIAXONE @ CEPHAZONE PHARMA

@

@

TEVA PHARMS

INJECTABLE; INJECTION CEFTRIAXONE

HOSPIRA INC

+ SANDOZ INC

+

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

A065294

A065294

A065294

A065294

A065294

A065227

A065227

A065227

A065227

A202563

A202563

A065204

A065204

002

003

003

004

004

001

002

003

004

001

002

001

002

Mar 26, 2007

Mar 26, 2007

Mar 26, 2007

Mar 26, 2007

Mar 26, 2007

Mar 15, 2007

Mar 15, 2007

Mar 15, 2007

Mar 15, 2007

Aug 20, 2012

Aug 20, 2012

May 03, 2005

May 03, 2005

Nov

Nov

Nov

Nov

Nov

Oct

Oct

Oct

Oct

Aug

Aug

Mar

Mar

DISC

DISC

DISC

DISC

DISC

CAHN

CAHN

CAHN

CAHN

NEWA

NEWA

CRLD

CRLD

CEFUROXIME AXETIL

TABLET; ORAL CEFUROXIME AXETIL @ RANBAXY LABS LTD

@

@

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A065043

A065043

A065043

003

002

001

Feb 15, 2002

Feb 15, 2002

Feb 15, 2002

Apr

Apr

Apr

DISC

DISC

DISC

CEFUROXIME SODIUM

AB

AB

AP

AP

AP

AP

INJECTABLE; IM-IV CEFUROXIME SODIUM

TEVA PHARMS EQ 750MG BASE/VIAL

ZINACEF + COVIS PHARMA EQ 750MG BASE/VIAL

INJECTABLE; INJECTION CEFUROXIME SODIUM

TEVA PHARMS EQ 1.5GM BASE/VIAL

EQ 7.5GM BASE/VIAL

ZINACEF + COVIS PHARMA EQ 1.5GM BASE/VIAL

+ EQ 7.5GM BASE/VIAL

ZINACEF IN PLASTIC CONTAINER + COVIS PHARMA EQ 15MG BASE/ML

+ EQ 30MG BASE/ML

A064192

N050558

A064192

A064191

N050558

N050558

N050643

N050643

002

002

001

001

003

004

001

002

Apr 16, 1998

Oct 19, 1983

Apr 16, 1998

Apr 16, 1998

Oct 19, 1983

Oct 23, 1986

Apr 28, 1989

Apr 28, 1989

Oct

Apr

Oct

Oct

Apr

Apr

Apr

Apr

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CEPHALEXIN

FOR SUSPENSION; ORAL KEFLEX @ SHIONOGI INC

@

@

EQ 100MG BASE/ML

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

N050406

N050406

N050406

003

001

002

Jul

Jul

Jul

CAHN

CAHN

CAHN

CEPHAPIRIN SODIUM

INJECTABLE; INJECTION CEPHAPIRIN SODIUM @ HIKMA MAPLE

@

@

@

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 20GM BASE/VIAL

A062720

A062720

A062720

A062720

001

002

003

004

Jul 02, 1987

Jul 02, 1987

Jul 02, 1987

Jul 02, 1987

Oct

Oct

Oct

Oct

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 34: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-25

CETIRIZINE HYDROCHLORIDE

SYRUP; ORAL CETIRIZINE HYDROCHLORIDE

AA

@ RANBAXY LABS LTD

SILARX

5MG/5ML

5MG/5ML

A077472

A078876

001

001

Jun 18, 2008

May 11, 2012

Jul

Apr

DISC

NEWA

CHLORAMBUCIL

TABLET; ORAL LEUKERAN

+ ASPEN GLOBAL INC 2MG N010669 002 May CAHN

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

SUSPENSION, EXTENDED RELEASE; ORAL HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX

AB CORNERSTONE THERAP EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML

A091671 001 Jun 29, 2012 Jun NEWA

CHLORPROMAZINE HYDROCHLORIDE

INJECTABLE; INJECTION CHLORPROMAZINE HYDROCHLORIDE

+ HIKMA MAPLE 25MG/ML A083329 001 Oct CAHN

CHLORTHALIDONE

TABLET; ORAL CHLORTHALIDONE

>D>

>D>

>A>

>A>

@ CLONMEL HLTHCARE

@

@ DAVA PHARMS INC

@

25MG

50MG

25MG

50MG

A087451

A087450

A087451

A087450

001

001

001

001

Nov

Nov

Nov

Nov

CAHN

CAHN

CAHN

CAHN

CHOLESTYRAMINE

POWDER; ORAL LOCHOLEST @ SANDOZ

@

LOCHOLEST LIGHT

EQ 4GM RESIN/PACKET

EQ 4GM RESIN/SCOOPFUL

A074561

A074561

001

002

Aug 15, 1996

Aug 15, 1996

Oct

Oct

DISC

DISC

@ SANDOZ

@

EQ 4GM RESIN/SCOOPFUL

EQ 4GM RESIN/PACKET

A074562

A074562

002

001

Aug 15, 1996

Aug 15, 1996

Oct

Oct

DISC

DISC

CHOLINE C-11

INJECTABLE; INTRAVENOUS CHOLINE C-11

+ MCPRF 4-33.1mCi/ML N203155 001 Sep 12, 2012 Sep NEWA

CICLESONIDE

AEROSOL, METERED; INHALATION ALVESCO

NYCOMED GMBH

+

AEROSOL, METERED; NASAL ZETONNA

+ NYCOMED GMBH

SPRAY, METERED; NASAL OMNARIS

0.08MG/INH

0.16MG/INH

0.037MG/INH

N021658

N021658

N202129

002

003

001

Jan 10, 2008

Jan 10, 2008

Jan 20, 2012

May

May

Jan

CAHN

CAHN

NEWA

+ NYCOMED GMBH 0.05MG/INH N022004 001 Oct 20, 2006 May CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 35: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-26

CICLOPIROX

CREAM; TOPICAL CICLOPIROX

AB FOUGERA PHARMS 0.77% A076435 001 Dec 29, 2004 Jan CAHN

GEL; TOPICAL CICLOPIROX

AB

AB

FOUGERA PHARMS

GLENMARK GENERICS

0.77%

0.77%

A077896

A091595

001

001

Jun 10, 2008

Feb 29, 2012

Jan

Feb

CAHN

NEWA

SHAMPOO; TOPICAL CICLOPIROX

AT

AT

FOUGERA PHARMS

WATSON LABS INC

1%

1%

A090146

A090490

001

001

May 25, 2010

Nov 24, 2009

Jan

Oct

CAHN

CAHN

SOLUTION; TOPICAL CICLOPIROX

AT MYLAN PHARMS INC

SUSPENSION; TOPICAL CICLOPIROX

8% A078567 001 Sep 18, 2007 Feb CAHN

AB FOUGERA PHARMS 0.77% A076422 001 Aug 06, 2004 Jan CAHN

CIDOFOVIR

INJECTABLE; INJECTION CIDOFOVIR

AP

AP

EMCURE PHARMS LTD

MYLAN LLC

VISTIDE

EQ 75MG BASE/ML

EQ 75MG BASE/ML

A202501

A201276

001

001

Jul 26, 2012

Jun 27, 2012

Jul

Jun

NEWA

NEWA

AP + GILEAD SCIENCES INC EQ 75MG BASE/ML N020638 001 Jun 26, 1996 Jun CFTG

CILOSTAZOL

TABLET; ORAL CILOSTAZOL

AB

AB

AB

AB

BIOKEY

MYLAN PHARMS INC

50MG

100MG

50MG

100MG

A077722

A077831

A077019

A077019

001

001

001

002

Sep 24, 2012

Sep 24, 2012

Nov 23, 2004

Nov 23, 2004

Sep

Sep

Sep

Sep

NEWA

NEWA

CAHN

CAHN

CIMETIDINE

TABLET; ORAL CIMETIDINE @ SANDOZ

@

@

@

@ VINTAGE PHARMS LLC

@

@

@

200MG

300MG

400MG

800MG

200MG

300MG

400MG

800MG

A074506

A074506

A074506

A074506

A074281

A074281

A074281

A074329

001

002

003

004

001

002

003

001

Jan 24, 1996

Jan 24, 1996

Jan 24, 1996

Jan 24, 1996

May 17, 1994

May 17, 1994

May 17, 1994

May 17, 1994

Oct

Oct

Oct

Oct

Sep

Sep

Sep

Sep

DISC

DISC

DISC

DISC

CAHN

CAHN

CAHN

CAHN

CIMETIDINE HYDROCHLORIDE

INJECTABLE; INJECTION CIMETIDINE HYDROCHLORIDE @ HOSPIRA

@

@ VINTAGE PHARMS LLC

EQ 300MG BASE/2ML

EQ 300MG BASE/2ML

EQ 300MG BASE/2ML

A074345

A074344

A074005

001

001

001

Jan 31, 1995

Jan 31, 1995

Aug 31, 1994

Jun

Jun

Sep

DISC

DISC

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 36: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-27

SOLUTION; ORAL CIMETIDINE HYDROCHLORIDE @ VINTAGE PHARMS LLC EQ 300MG BASE/5ML A074251 001 Dec 22, 1994 Sep CAHN

CIPROFLOXACIN

INJECTABLE; INJECTION CIPROFLOXACIN @ TEVA PARENTERAL 200MG/20ML (10MG/ML)

@ 400MG/40ML (10MG/ML)

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

A077782

A077782

001

002

Aug 28, 2006

Aug 28, 2006

Mar

Jan

DISC

DISC

@ BAXTER HLTHCARE

@

200MG/100ML

400MG/200ML

A077888

A077888

001

002

Mar 18, 2008

Mar 18, 2008

Jun

Jun

DISC

DISC

CIPROFLOXACIN HYDROCHLORIDE

TABLET; ORAL CIPROFLOXACIN HYDROCHLORIDE @ PLIVA

@

@

@

EQ 100MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 750MG BASE

A076426

A076426

A076426

A076426

001

002

003

004

Jun 15, 2005

Jun 15, 2005

Jun 15, 2005

Jun 15, 2005

Jan

Jan

Jan

Jan

DISC

DISC

DISC

DISC

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL CIPROFLOXACIN EXTENDED RELEASE

AB DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE A077701 002 Oct 31, 2007 Apr NEWA

CISATRACURIUM BESYLATE

INJECTABLE; INJECTION CISATRACURIUM BESYLATE

AP SANDOZ INC EQ 2MG BASE/ML

CISATRACURIUM BESYLATE PRESERVATIVE FREE

A200159 001 Feb 03, 2012 Jan NEWA

AP

AP

SANDOZ INC

NIMBEX

EQ 2MG BASE/ML

EQ 10MG BASE/ML

A200154

A200154

001

002

Feb 03, 2012

Feb 03, 2012

Jan

Jan

NEWA

NEWA

AP + ABBOTT EQ 2MG BASE/ML

NIMBEX PRESERVATIVE FREE

N020551 001 Dec 15, 1995 Jan CFTG

AP

AP

+

+

ABBOTT EQ 2MG BASE/ML

EQ 10MG BASE/ML

N020551

N020551

003

002

Dec 15, 1995

Dec 15, 1995

Jan

Jan

CFTG

CFTG

CISPLATIN

INJECTABLE; INJECTION CISPLATIN

AP ONCO THERAPIES LTD

@ TEVA PARENTERAL

1MG/ML

1MG/ML

A091062

A074814

001

001

Apr 18, 2012

May 16, 2000

Apr

Mar

NEWA

DISC

CITALOPRAM HYDROBROMIDE

CAPSULE; ORAL CITALOPRAM HYDROBROMIDE

MYLAN PHARMS INC

+

TABLET; ORAL CITALOPRAM HYDROBROMIDE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

A077668

A077668

A077668

001

002

003

Feb 28, 2007

Feb 28, 2007

Feb 28, 2007

Sep

Sep

Sep

CAHN

CAHN

CAHN

AB

AB

AB

MYLAN PHARMS INC EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

A077037

A077037

A077037

001

002

003

Nov 05, 2004

Nov 05, 2004

Nov 05, 2004

Sep

Sep

Sep

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 37: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-28

TABLET; ORAL CITALOPRAM HYDROBROMIDE

AB

AB

AB

@ SANDOZ

@

@

TEVA PHARMS

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

A077035

A077035

A077035

A077048

A077048

A077048

001

002

003

001

002

003

Oct 28, 2004

Oct 28, 2004

Oct 28, 2004

Nov 16, 2004

Nov 16, 2004

Nov 16, 2004

Aug

Aug

Aug

Aug

Aug

Aug

DISC

DISC

DISC

CAHN

CAHN

CAHN

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

FOR SOLUTION; ORAL PREPOPIK

+ FERRING PHARMS AS 12GM/PACKET;3.5GM/PACKET;10MG/PACKET

N202535 001 Jul 16, 2012 Jul NEWA

CLARITHROMYCIN

TABLET; ORAL CLARITHROMYCIN

AB

AB

AUROBINDO 250MG

500MG

TABLET, EXTENDED RELEASE; ORAL CLARITHROMYCIN

A065489

A065489

001

002

Jul 25, 2012

Jul 25, 2012

Jul

Jul

NEWA

NEWA

@ SANDOZ 500MG A065250 001 Aug 25, 2005 Aug DISC

CLINDAMYCIN HYDROCHLORIDE

CAPSULE; ORAL CLINDAMYCIN HYDROCHLORIDE

AB

AB

AB

MYLAN PHARMS INC EQ 75MG BASE

EQ 150MG BASE

EQ 300MG BASE

A091225

A091225

A091225

001

002

003

May 31, 2011

May 31, 2011

May 31, 2011

Sep

Sep

Sep

CAHN

CAHN

CAHN

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION; ORAL CLINDAMYCIN PALMITATE HYDROCHLORIDE

AA LYNE EQ 75MG BASE/5ML A201821 001 Aug 28, 2012 Aug NEWA

CLINDAMYCIN PHOSPHATE

CREAM; VAGINAL CLINDAMYCIN PHOSPHATE

AB FOUGERA PHARMS

GEL; TOPICAL CLINDAMYCIN PHOSPHATE

EQ 2% BASE A065139 001 Dec 27, 2004 Jan CAHN

AB FOUGERA PHARMS EQ 1% BASE A064160 001 Jan 28, 2000 Jan CAHN

INJECTABLE; INJECTION CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP

AP

AP

+

+

+

PHARMACIA AND UPJOHN

CLINDAMYCIN PHOSPHATE

EQ 6MG BASE/ML

EQ 12MG BASE/ML

EQ 18MG BASE/ML

N050639

N050639

N050639

001

002

003

Aug 30, 1989

Aug 30, 1989

Apr 10, 1991

May

May

May

CFTG

CFTG

CFTG

AP

@ HIKMA MAPLE EQ 150MG BASE/ML

@ EQ 150MG BASE/ML

@ EQ 150MG BASE/ML

EQ 150MG BASE/ML

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

A062953

A062806

A063068

A062889

001

001

001

001

Apr 21, 1988

Oct 15, 1987

Aug 28, 1989

Apr 25, 1988

Oct

Oct

Oct

Oct

CAHN

CAHN

CAHN

CAHN

AP

AP

SANDOZ INC EQ 6MG BASE/ML

EQ 12MG BASE/ML

A201692

A201692

001

002

May 31, 2012

May 31, 2012

May

May

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 38: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-29

INJECTABLE; INJECTION CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

AP SANDOZ INC EQ 18MG BASE/ML

LOTION; TOPICAL CLINDAMYCIN PHOSPHATE

AB FOUGERA PHARMS EQ 1% BASE

SOLUTION; TOPICAL CLINDAMYCIN PHOSPHATE

AT FOUGERA PHARMS EQ 1% BASE

@ G AND W LABS INC EQ 1% BASE

@ RENAISSANCE PHARMA EQ 1% BASE

CLINDAMYCIN PHOSPHATE; TRETINOIN

GEL; TOPICAL VELTIN

BX + STIEFEL GSK 1.2%;0.025%

CLOBAZAM

TABLET; ORAL

ONFI

LUNDBECK LLC 5MG

10MG

+ 20MG

CLOBETASOL PROPIONATE

AEROSOL, FOAM; TOPICAL CLOBETASOL PROPIONATE

AB1 PERRIGO ISRAEL 0.05%

AB2 0.05%

OLUX AB1 + STIEFEL LABS INC 0.05%

OLUX E AB2 + STIEFEL LABS INC 0.05%

CREAM; TOPICAL

CLOBETASOL PROPIONATE @ G AND W LABS INC 0.05%

@ RENAISSANCE PHARMA 0.05%

CLOBETASOL PROPIONATE (EMOLLIENT) AB2 FOUGERA PHARMS 0.05%

@ RENAISSANCE PHARMA 0.05%

TEMOVATE AB1 + FOUGERA PHARMS 0.05%

GEL; TOPICAL CLOBETASOL PROPIONATE

AB FOUGERA PHARMS 0.05%

TEMOVATE AB + FOUGERA PHARMS 0.05%

LOTION; TOPICAL CLOBETASOL PROPIONATE

AB TARO 0.05%

OINTMENT; TOPICAL CLOBETASOL PROPIONATE

AB FOUGERA PHARMS 0.05%

@ RENAISSANCE PHARMA 0.05%

TEMOVATE AB + FOUGERA PHARMS 0.05%

A201692

A065067

A065254

A062811

A064108

N050803

N202067

N202067

N202067

A077763

A201402

N021142

N022013

A074139

A075338

A075430

A075733

N019322

A075368

N020337

A200302

A074407

A075057

N019323

003

001

001

001

001

001

001

002

003

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

MayMay 31, 2012 NEWA

JanJan 31, 2002 CAHN

JanFeb 14, 2006 CAHN

OctSep 01, 1988 CAHN

SepSep 27, 1996 CAHN

MayJul 16, 2010 CRLD

MarOct 21, 2011 CAHN

MarOct 21, 2011 CAHN

MarOct 21, 2011 CAHN

JulMar 10, 2008 CTEC

JulAug 14, 2012 NEWA

JulMay 26, 2000 CTEC

JulJan 12, 2007 CFTG

JunAug 03, 1994 CAHN

AugFeb 09, 2001 CAHN

JanMay 26, 1999 CAHN

AugAug 22, 2001 CAHN

JanDec 27, 1985 CAHN

JanFeb 15, 2000 CAHN

JanApr 29, 1994 CAHN

JunJul 02, 2012 NEWA

JanFeb 23, 1996 CAHN

AugAug 12, 1998 CAHN

JanDec 27, 1985 CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 39: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-30

SHAMPOO; TOPICAL CLOBETASOL PROPIONATE

AB PERRIGO ISRAEL

SOLUTION; TOPICAL CLOBETASOL PROPIONATE

0.05% A090974 001 Aug 09, 2012 Jul NEWA

AT FOUGERA PHARMS

@ G AND W LABS INC

TEMOVATE

0.05%

0.05%

A075391

A074331

001

001

Feb 08, 1999

Dec 15, 1995

Jan

Jun

CAHN

CAHN

AT + FOUGERA PHARMS 0.05% N019966 001 Feb 22, 1990 Jan CAHN

CLONAZEPAM

TABLET; ORAL CLONAZEPAM

AB

AB

AB

MYLAN PHARMS INC 0.5MG

1MG

2MG

A074940

A074940

A074940

001

002

003

Oct 30, 1997

Oct 30, 1997

Oct 30, 1997

Sep

Sep

Sep

CAHN

CAHN

CAHN

CLONIDINE HYDROCHLORIDE

INJECTABLE; INJECTION DURACLON

AP

AP

MYLAN INSTITUTIONAL 1 MG/10 ML (0.1 MG/ML)

+ 5 MG/10 ML (0.5 MG/ML)

TABLET, EXTENDED RELEASE; ORAL KAPVAY

N020615

N020615

001

002

Oct 02, 1996

Apr 27, 1999

Feb

Feb

CAHN

CAHN

SHIONOGI INC 0.2MG N022331 004 Sep 28, 2010 May CMFD

CLOPIDOGREL BISULFATE

TABLET; ORAL CLOPIDOGREL BISULFATE

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

APOTEX INC

AUROBINDO PHARMA LTD

DR REDDYS LABS INC

DR REDDYS LABS LTD

GATE PHARMS

MYLAN PHARMS INC

ROXANE

SUN PHARMA GLOBAL

TEVA

TEVA PHARMS

TORRENT PHARMS LTD

WOCKHARDT LTD

ZYDUS PHARMS USA INC

PLAVIX

EQ 75MG BASE

EQ 75MG BASE

EQ 75MG BASE

EQ 300MG BASE

EQ 300MG BASE

EQ 75MG BASE

EQ 300MG BASE

EQ 75MG BASE

EQ 75MG BASE

EQ 75MG BASE

EQ 300MG BASE

EQ 75MG BASE

EQ 75MG BASE

EQ 300MG BASE

EQ 75MG BASE

A076274

A090540

A076273

A091023

A091216

A077665

A077665

A078004

A090494

A076999

A090625

A090844

A202266

A202266

A201686

001

001

001

001

001

001

002

001

001

001

001

001

001

002

001

May 17, 2012

May 17, 2012

Jan 14, 2008

May 17, 2012

May 17, 2012

May 17, 2012

May 17, 2012

May 17, 2012

May 17, 2012

May 17, 2012

May 17, 2012

May 17, 2012

Aug 14, 2012

Nov 20, 2012

Oct 10, 2012

Apr

Apr

Mar

Apr

Apr

Apr

Apr

Apr

Apr

Apr

Apr

Apr

Jul

Nov

Sep

NEWA

NEWA

CMFD

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB

AB +

SANOFI AVENTIS US EQ 75MG BASE

EQ 300MG BASE

N020839

N020839

001

002

Nov 17, 1997

Sep 20, 2007

Mar

Apr

CTEC

CTEC

CLORAZEPATE DIPOTASSIUM

CAPSULE; ORAL TRANXENE @ LUNDBECK LLC

@

@

3.75MG

7.5MG

15MG

N017105

N017105

N017105

001

002

003

Mar

Mar

Mar

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 40: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-31

AB

AB

AB

TABLET; ORAL TRANXENE

LUNDBECK LLC

+

TRANXENE SD @ LUNDBECK LLC

@

3.75MG

7.5MG

15MG

11.25MG

22.5MG

N017105

N017105

N017105

N017105

N017105

006

007

008

005

004

Mar

Mar

Mar

Mar

Mar

CAHN

CAHN

CAHN

CAHN

CAHN

CLOTRIMAZOLE

AB

CREAM; TOPICAL CLOTRIMAZOLE

FOUGERA PHARMS 1% A078338 001 Sep 02, 2008 Jan CAHN

CLOZAPINE

TABLET, ORALLY DISINTEGRATING; ORAL FAZACLO ODT

JAZZ 12.5MG

25MG

@ 50MG

+ 100MG

150MG

200MG

JAZZ PHARMS III 12.5MG

25MG

@ 50MG

+ 100MG

150MG

200MG

N021590

N021590

N021590

N021590

N021590

N021590

N021590

N021590

N021590

N021590

N021590

N021590

004

001

003

002

005

006

004

001

003

002

005

006

May 30, 2007

Feb 10, 2004

Jun 03, 2005

Feb 10, 2004

Jul 09, 2010

Jul 09, 2010

May 30, 2007

Feb 10, 2004

Jun 03, 2005

Feb 10, 2004

Jul 09, 2010

Jul 09, 2010

Apr

Apr

Apr

Apr

Apr

Apr

Jun

Jun

Jun

Jun

Jun

Jun

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL STRIBILD

+ GILEAD SCIENCES INC 150MG;150MG;200MG;300MG 001 N203100 Aug 27, 2012 Aug NEWA

AA

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

TRIS PHARMA INC 10MG/5ML;6.25MG/5ML A200386 001 Jun 29, 2012 Jun NEWA

COLCHICINE

TABLET; ORAL COLCRYS

+ TAKEDA PHARMS USA 0.6MG N022352 001 Jul 29, 2009 Oct CAHN

COLISTIMETHATE SODIUM

AP

INJECTABLE; INJECTION COLISTIMETHATE SODIUM

EMCURE PHARMS LTD EQ 150MG BASE/VIAL A202359 001 Sep 28, 2012 Sep NEWA

COPPER

INTRAUTERINE DEVICE; INTRAUTERINE PARAGARD T 380A

+ TEVA WOMENS 309MG/COPPER N018680 001 Nov 15, 1984 May CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 41: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-32

COSYNTROPIN

INJECTABLE; INJECTION COSYNTROPIN

AP

AP

INNOPHARMA INC

SANDOZ

0.25MG/VIAL

0.25MG/VIAL

A202147

A202147

001

001

Jun 29, 2012

Jun 29, 2012

Jun

Sep

NEWA

CAHN

CROMOLYN SODIUM

AEROSOL, METERED; INHALATION INTAL @ KING PFIZER

CONCENTRATE; ORAL GASTROCROM

0.8MG/INH N018887 001 Dec 05, 1985 Jun DISC

>D>

>A>

AA

AA

AA

AA

+ JAZZ PHARMS COMMERCL

+ JAZZ PHARMS INTL

+

+ MEDA PHARMS

SOLUTION; INHALATION CROMOLYN SODIUM

100MG/5ML

100MG/5ML

100MG/5ML

100MG/5ML

N020479

N020479

N020479

N020479

001

001

001

001

Feb 29, 1996

Feb 29, 1996

Feb 29, 1996

Feb 29, 1996

Mar

Nov

Jun

Nov

CAHN

CAHN

CAHN

CAHN

AN + TEVA PHARMS 10MG/ML A075271 001 Jan 18, 2000 Sep CAHN

CYANOCOBALAMIN

INJECTABLE; INJECTION CYANOCOBALAMIN @ HIKMA MAPLE 1MG/ML A080515 002 Oct CAHN

CYCLOBENZAPRINE HYDROCHLORIDE

TABLET; ORAL CYCLOBENZAPRINE HYDROCHLORIDE

AB

AB

AB

AB

+

MYLAN PHARMS INC

PROSAM LABS

FLEXERIL

5MG

10MG

5MG

10MG

A073144

A073144

A077291

A077209

002

001

001

001

Feb 03, 2006

May 30, 1991

Feb 03, 2006

Oct 04, 2005

Jul

Jul

Feb

Feb

CRLD

CRLD

CAHN

CAHN

@ JANSSEN RES AND DEV

@

5MG

10MG

N017821

N017821

001

002

Jul

Jul

DISC

DISC

CYCLOPHOSPHAMIDE

INJECTABLE; INJECTION CYTOXAN

AP

AP

AP

+

+

+

BAXTER HLTHCARE 500MG/VIAL

1GM/VIAL

2GM/VIAL

N012142

N012142

N012142

003

004

005

Aug 30, 1982

Aug 30, 1982

Apr

Apr

Apr

CRLD

CRLD

CRLD

CYCLOSPORINE

CAPSULE; ORAL CYCLOSPORINE

AB1

AB1

WATSON LABS INC

SOLUTION; ORAL CYCLOSPORINE

25MG

100MG

A065044

A065044

002

001

Dec 20, 2000

Dec 20, 2000

May

May

CAHN

CAHN

AB1 ABBVIE 100MG/ML A065025 001 Mar 03, 2000 Sep CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 42: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-33

CYSTEAMINE HYDROCHLORIDE

SOLUTION/DROPS; OPHTHALMICCYSTARAN

+ SIGMA TAU EQ 0.44% BASE N200740 001 Oct 02, 2012 Oct NEWA

CYTARABINE

AP

INJECTABLE; INJECTION CYTARABINE

ONCO THERAPIES LTD 100MG/ML A201784 001 Jan 30, 2012 Jan NEWA

DACTINOMYCIN

AP

INJECTABLE; INJECTION COSMEGEN

+ LUNDBECK LLC 0.5MG/VIAL N050682 001 Mar CAHN

DANTROLENE SODIUM

CAPSULE; ORAL DANTROLENE SODIUM @ MIKAH PHARMA

@

@

25MG

50MG

100MG

A076686

A076686

A076686

001

002

003

Oct 24, 2005

Oct 24, 2005

Oct 24, 2005

Jul

Jul

Jul

CAHN

CAHN

CAHN

DAPIPRAZOLE HYDROCHLORIDE

SOLUTION/DROPS; OPHTHALMICDAPIPRAZOLE HYDROCHLORIDE @ FERA PHARMS 0.5% N019849 001 Dec 31, 1990 Jul CTNA

DARUNAVIR ETHANOLATE

>D>

>A>

>A>

SUSPENSION; ORAL PREZISTA

+ JANSSEN PRODS

TABLET; ORAL PREZISTA

JANSSEN PRODS

@

+

+

+

EQ 100MG BASE/ML

EQ 75MG BASE

EQ 150MG BASE

EQ 300MG BASE

EQ 400MG BASE

EQ 600MG BASE

EQ 600MG BASE

EQ 600MG BASE

EQ 800MG BASE

N202895

N021976

N021976

N021976

N021976

N021976

N021976

N021976

N021976

001

004

005

001

003

002

002

002

006

Dec 16, 2011

Dec 18, 2008

Dec 18, 2008

Jun 23, 2006

Oct 21, 2008

Feb 25, 2008

Feb 25, 2008

Feb 25, 2008

Nov 09, 2012

Feb

Feb

Feb

Feb

Feb

Nov

Nov

Feb

Nov

CAHN

CAHN

CAHN

CAHN

CAHN

CRLD

CRLD

CAHN

NEWA

DEMECLOCYCLINE HYDROCHLORIDE

AB

TABLET; ORAL DECLOMYCIN @ COREPHARMA 150MG

@ 300MG

DEMECLOCYCLINE HYDROCHLORIDE + AMNEAL PHARM 300MG

N050261

N050261

A065425

002

003

002 Feb 27, 2008

Jul

Jul

Jul

DISC

DISC

CRLD

DESFLURANE

LIQUID; INHALATION SUPRANE

+ BAXTER HLTHCARE 99.9% N020118 001 Sep 18, 1992 Jul CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 43: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-34

DESIPRAMINE HYDROCHLORIDE

TABLET; ORAL NORPRAMIN

AB SANOFI AVENTIS US 50MG N014399 003 Oct CRLD

DESLORATADINE

TABLET; ORAL DESLORATADINE

AB

AB

BELCHER PHARMS

MYLAN PHARMS INC

5MG

5MG

A078355

A078351

001

001

Apr 19, 2012

Feb 10, 2012

Apr

Jan

NEWA

NEWA

DESMOPRESSIN ACETATE

SOLUTION; NASAL DDAVP

AB + SANOFI AVENTIS US 0.01% N017922 001 Mar CFTG

DESMOPRESSIN ACETATE AB SUN PHARM INDS 0.01% A077212 001 Apr 12, 2012 Mar NEWA

DESOGESTREL; ETHINYL ESTRADIOL

AB

TABLET; ORAL-28 EMOQUETTE

VINTAGE PHARMS LLC

MIRCETTE

0.15MG;0.03MG A076675 001 Feb 25, 2011 Sep CAHN

AB + TEVA BRANDED PHARM

VIORELE

0.15MG,N/A;0.02MG,0.01MG N020713 001 Apr 22, 1998 Jun CAHN

AB GLENMARK GENERICS 0.15MG,N/A;0.02MG,0.01MG A091346 001 Apr 02, 2012 Mar NEWA

DESONIDE

GEL; TOPICAL DESONATE

>A>

>D>

+ BAYER HLTHCARE

+ INTENDIS

LOTION; TOPICAL DESONIDE

0.05%

0.05%

N021844

N021844

001

001

Oct 20, 2006

Oct 20, 2006

Nov

Nov

CAHN

CAHN

AB FOUGERA PHARMS

OINTMENT; TOPICAL DESONIDE

0.05% A075860 001 Mar 19, 2002 Jan CAHN

AB FOUGERA PHARMS 0.05% A075751 001 Mar 12, 2001 Jan CAHN

DESOXIMETASONE

CREAM; TOPICAL DESOXIMETASONE

AB FOUGERA PHARMS

TOPICORT

0.25% A078369 001 Jun 29, 2010 Jan CAHN

AB

+

+

+

TARO

@ TARO PHARMS NORTH

TOPICORT LP

0.05%

0.25%

0.25%

0.25%

A073210

A073193

A073193

N017856

001

001

001

001

Nov 30, 1990

Nov 30, 1990

Nov 30, 1990

Apr

Sep

Apr

Apr

CTNA

CTEC

CTNA

DISC

@ TARO PHARMS NORTH

GEL; TOPICAL TOPICORT

0.05% N018309 001 Apr DISC

AB + TARO

@ TARO PHARMS NORTH

0.05%

0.05%

A074904

N018586

001

001

Jul 14, 1998

Mar 29, 1982

Apr

Apr

CTNA

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 44: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-35

OINTMENT; TOPICAL DESOXIMETASONE

AB

AB +

FOUGERA PHARMS

TARO

TOPICORT

0.25%

0.25%

A078657

A074286

001

001

Sep 28, 2012

Jun 07, 1996

Sep

Mar

NEWA

CRLD

AB +

+

TARO

@ TARO PHARMS NORTH

0.25%

0.25%

0.25%

A074286

A074286

N018763

001

001

001

Jun 07, 1996

Jun 07, 1996

Sep 30, 1983

Sep

Apr

Mar

CTEC

CTNA

DISC

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE; INJECTION DEXAMETHASONE SODIUM PHOSPHATE

AP

AP

+

+

APP PHARMS LLC

@ HIKMA MAPLE

EQ 10MG PHOSPHATE/ML

EQ 4MG PHOSPHATE/ML

EQ 10MG PHOSPHATE/ML

A040572

A084282

A087702

001

001

001

Apr 22, 2005

Sep 07, 1982

Feb

Oct

Oct

CRLD

CAHN

CAHN

DEXRAZOXANE HYDROCHLORIDE

INJECTABLE; INJECTION TOTECT

+ APRICUS PHARMS EQ 500MG BASE/VIAL N022025 001 Sep 06, 2007 Jun CAHN

DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE; ORAL DEXEDRINE

>A> AB AMEDRA PHARMS 5MG N017078 001 Nov CAHN

>A> AB 10MG N017078 002 Nov CAHN

>A> AB + 15MG N017078 003 Nov CAHN

>D> AB COREPHARMA 5MG N017078 001 Nov CAHN

>D> AB 10MG N017078 002 Nov CAHN

>D> AB + 15MG N017078 003 Nov CAHN

DEXTROAMPHETAMINE SULFATE >A>

>A>

>A>

AB

AB

AB

ACTAVIS ELIZABETH 5MG

10MG

15MG

TABLET; ORAL DEXTROAMPHETAMINE SULFATE

A203901

A203901

A203901

001

002

003

Nov 30, 2012

Nov 30, 2012

Nov 30, 2012

Nov

Nov

Nov

NEWA

NEWA

NEWA

>D>

>A>

>D>

>A>

AA

AA

NESHER PHARMS

@

@

@ VINTAGE PHARMS LLC

5MG

5MG

10MG

10MG

5MG

A040365

A040365

A040367

A040367

A040299

001

001

001

001

001

Oct 31, 2002

Oct 31, 2002

Oct 31, 2002

Oct 31, 2002

May 13, 1999

Nov

Nov

Nov

Nov

Sep

DISC

DISC

DISC

DISC

CAHN

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

AA TRIS PHARMA INC 15MG/5ML;6.25MG/5ML A091687 001 Jun 28, 2012 Jun NEWA

DIAZEPAM

INJECTABLE; INJECTION DIAZEPAM @ HIKMA MAPLE

@

@

@

@

@

5MG/ML

5MG/ML

5MG/ML

5MG/ML

5MG/ML

5MG/ML

A071310

A070311

A070312

A070313

A071308

A071309

001

001

001

001

001

001

Jul 17, 1987

Dec 16, 1985

Dec 16, 1985

Dec 16, 1985

Jul 17, 1987

Jul 17, 1987

Jul

Jul

Jul

Jul

Jul

Jul

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 45: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-36

INJECTABLE; INJECTION DIAZEPAM @ HOSPIRA 5MG/ML A071584 001 Oct 13, 1987 Apr DISC

DICLOFENAC POTASSIUM

CAPSULE; ORAL ZIPSOR

+ DEPOMED INC 25MG N022202 001 Jun 16, 2009 Jun CAHN

DICLOFENAC SODIUM

AB

AB

TABLET, DELAYED RELEASE; ORAL DICLOFENAC SODIUM

MYLAN PHARMS INC 50MG

75MG

A075281

A075281

002

003

Feb 12, 2002

Feb 12, 2002

Sep

Sep

CAHN

CAHN

AB

AB

AB

AB

DICLOFENAC SODIUM; MISOPROSTOL

TABLET, DELAYED RELEASE; ORAL ARTHROTEC

GD SEARLE LLC 50MG;0.2MG

+ 75MG;0.2MG

DICLOFENAC SODIUM AND MISOPROSTOL WATSON LABS INC 50MG;0.2MG

75MG;0.2MG

N020607

N020607

A201089

A201089

001

002

001

002

Dec 24, 1997

Dec 24, 1997

Jul 09, 2012

Jul 09, 2012

Jun

Jun

Jun

Jun

CFTG

CFTG

NEWA

NEWA

DIDANOSINE

>D>

>A>

AB

AB

AB

AB

CAPSULE, DELAYED REL PELLETS; ORAL DIDANOSINE

MYLAN PHARMS INC 125MG

200MG

250MG

400MG

TABLET, CHEWABLE; ORAL DIDANOSINE

AUROBINDO 100MG

150MG

200MG

+ 200MG

200MG

A090788

A090788

A090788

A090788

A077275

A077275

A077275

A077275

A077275

001

002

003

004

001

002

003

003

003

Apr 08, 2010

Apr 08, 2010

Apr 08, 2010

Apr 08, 2010

Aug 14, 2012

Aug 14, 2012

Aug 14, 2012

Aug 14, 2012

Aug 14, 2012

Sep

Sep

Sep

Sep

Jul

Jul

Nov

Nov

Jul

CAHN

CAHN

CAHN

CAHN

NEWA

NEWA

CRLD

CRLD

NEWA

DIFLORASONE DIACETATE

>D>

>A>

BX

AB1

AB

CREAM; TOPICAL DIFLORASONE DIACETATE

+ FOUGERA PHARMS

+

PSORCON @ SANOFI AVENTIS US

@ VALEANT PHARM NORTH

OINTMENT; TOPICAL DIFLORASONE DIACETATE

FOUGERA PHARMS

0.05%

0.05%

0.05%

0.05%

0.05%

A076263

A075187

N020205

N020205

A075374

001

001

001

001

001

Dec 20, 2002

Mar 30, 1998

Nov 20, 1992

Nov 20, 1992

Apr 27, 1999

Jan

Jan

Nov

Nov

Jan

CAHN

CAHN

CAHN

CAHN

CAHN

DIFLUNISAL

AB

AB

TABLET; ORAL DIFLUNISAL

EMCURE PHARMS USA

+ TEVA

500MG

500MG

A202845

A073673

001

001

Mar 08, 2012

Jul 31, 1992

Feb

Feb

NEWA

CTEC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 46: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-37

DIGOXIN

INJECTABLE; INJECTION DIGOXIN

AP HIKMA MAPLE

@ HOSPIRA

TABLET; ORAL DIGOXIN

0.25MG/ML

0.25MG/ML

A083391

A040093

001

001 May 16, 1996

Jul

Jun

CAHN

DISC

@ MYLAN PHARMS INC

@

0.125MG

0.25MG

A040282

A040282

001

002

Dec 23, 1999

Dec 23, 1999

Jul

Jul

CAHN

CAHN

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL DILTIAZEM HYDROCHLORIDE

>A>

AB4

AB4

AB4

AB4

AB4

AB4

AB3

ACTAVIS ELIZABETH

ACTAVIS INC

120MG

180MG

240MG

300MG

360MG

420MG

360MG

A091022

A091022

A091022

A091022

A091022

A091022

A202463

001

002

003

004

005

006

001

Sep 28, 2012

Sep 28, 2012

Sep 28, 2012

Sep 28, 2012

Sep 28, 2012

Sep 28, 2012

Dec 07, 2012

Sep

Sep

Sep

Sep

Sep

Sep

Nov

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

INJECTABLE; INJECTION DILTIAZEM HYDROCHLORIDE

AP

AP

AP

AGILA SPECLTS

HIKMA FARMACEUTICA

HIKMA MAPLE

@ TEVA PARENTERAL

5MG/ML

5MG/ML

5MG/ML

5MG/ML

A075375

A202651

A078538

A074894

001

001

001

001

Sep 30, 1999

Aug 09, 2012

Dec 17, 2008

Aug 26, 1997

Sep

Jul

Jul

Jan

CAHN

NEWA

CAHN

DISC

DINOPROSTONE

INSERT, EXTENDED RELEASE; VAGINAL CERVIDIL

+ FERRING CONTROLLED 10MG N020411 001 Mar 30, 1995 Jul CAHN

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLE; INJECTION BENADRYL @ MCNEIL CONS 50MG/ML

BENADRYL PRESERVATIVE FREE

N006146 002 Mar DISC

@ MCNEIL CONS 50MG/ML

DIPHENHYDRAMINE HYDROCHLORIDE

N009486 001 Mar DISC

AP

AP

+

+

@

BAXTER HLTHCARE

HIKMA MAPLE

50MG/ML

50MG/ML

50MG/ML

A080817

A080817

A083183

002

002

001

Apr

Jul

Jul

CRLD

CAHN

CAHN

DIPYRIDAMOLE

INJECTABLE; INJECTION DIPYRIDAMOLE

AP HIKMA MAPLE

@ TEVA PARENTERAL

TABLET; ORAL DIPYRIDAMOLE

5MG/ML

5MG/ML

A074521

A074952

001

001

Oct 18, 1996

Nov 26, 1997

Jul

Jan

CAHN

DISC

AB

AB

AB

PROSAM LABS 25MG

50MG

75MG

A040542

A040542

A040542

001

002

003

Apr 21, 2006

Apr 21, 2006

Apr 21, 2006

Feb

Feb

Feb

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 47: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-38

DISOPYRAMIDE PHOSPHATE

CAPSULE, EXTENDED RELEASE; ORAL DISOPYRAMIDE PHOSPHATE @ NESHER PHARMS EQ 150MG BASE A071200 001 Dec 15, 1987 Jun DISC

DIVALPROEX SODIUM

TABLET, EXTENDED RELEASE; ORAL DIVALPROEX SODIUM

AB

AB

DR REDDYS LABS LTD

REDDYS

EQ 250MG VALPROIC ACID

EQ 500MG VALPROIC ACID

A090161

A090070

001

001

Mar 15, 2012

Mar 12, 2012

Feb

Feb

NEWA

NEWA

DOCETAXEL

INJECTABLE; INJECTION DOCETAXEL

AP

AP

AP

AP

AP

AP

ACCORD HLTHCARE

APOTEX INC

TAXOTERE

20MG/ML (20MG/ML)

20MG/0.5ML (40MG/ML)

80MG/4ML (20MG/ML)

80MG/2ML (40MG/ML)

160MG/8ML (20MG/ML)

20MG/0.5ML (40MG/ML)

80MG/2ML (40MG/ML)

N201195

N201195

N201195

N201195

N201195

N022312

N022312

003

001

004

002

005

001

002

Apr 20, 2012

Jun 08, 2011

Apr 20, 2012

Jun 08, 2011

Apr 20, 2012

Jan 11, 2012

Jan 11, 2012

Apr

Jan

Apr

Jan

Apr

Jan

Jan

NEWA

CTEC

NEWA

CTEC

NEWA

NEWA

NEWA

AP

AP

+

+

SANOFI AVENTIS US 20MG/ML (20MG/ML)

80MG/4ML (20MG/ML)

N020449

N020449

003

004

Aug 03, 2010

Aug 02, 2010

Apr

Apr

CTEC

CTEC

DONEPEZIL HYDROCHLORIDE

TABLET; ORAL DONEPEZIL HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

INDICUS PHARMA

MACLEODS PHARMS LTD

MYLAN PHARMS INC

PRINSTON INC

ZYDUS PHARMS USA INC

5MG

10MG

5MG

10MG

5MG

10MG

5MG

10MG

5MG

10MG

A201634

A201634

A201146

A201146

A090521

A090521

A200292

A200292

A090100

A090100

001

002

001

002

001

002

001

002

001

002

Jun 13, 2012

Jun 13, 2012

Aug 17, 2012

Aug 17, 2012

May 31, 2011

May 31, 2011

May 31, 2011

May 31, 2011

Oct 24, 2012

Oct 24, 2012

Jul

Jul

Aug

Aug

Sep

Sep

Jun

Jun

Oct

Oct

NEWA

NEWA

NEWA

NEWA

CAHN

CAHN

CAHN

CAHN

NEWA

NEWA

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS; OPHTHALMICCOSOPT PF

+ MERCK SHARP DOHME EQ 2% BASE;EQ 0.5% BASE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

N202667 001 Feb 01, 2012 Feb NEWA

AT TEVA PHARMS EQ 2% BASE;EQ 0.5% BASE A078704 001 Sep 28, 2009 Sep CAHN

DOXAZOSIN MESYLATE

TABLET; ORAL DOXAZOSIN MESYLATE @ NESHER PHARMS

@

@

@

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

A075609

A075609

A075609

A075609

001

002

003

004

Oct 18, 2000

Oct 18, 2000

Oct 18, 2000

Oct 18, 2000

Feb

Feb

Feb

Feb

DISC

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 48: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-39

DOXEPIN HYDROCHLORIDE

CAPSULE; ORAL DOXEPIN HYDROCHLORIDE

>D> @ CLONMEL HLTHCARE EQ 10MG BASE A071685 001 Jan 05, 1988 Nov CAHN

>D> @ EQ 50MG BASE A071673 001 Jan 05, 1988 Nov CAHN

>D> @ EQ 75MG BASE A071674 001 Jan 05, 1988 Nov CAHN

>D> @ EQ 100MG BASE A071675 001 Jan 05, 1988 Nov CAHN

>D> @ EQ 150MG BASE A071676 001 Jan 05, 1988 Nov CAHN

>A> @ DAVA PHARMS INC EQ 10MG BASE A071685 001 Jan 05, 1988 Nov CAHN

>A> @ EQ 50MG BASE A071673 001 Jan 05, 1988 Nov CAHN

>A> @ EQ 75MG BASE A071674 001 Jan 05, 1988 Nov CAHN

>A> @ EQ 100MG BASE A071675 001 Jan 05, 1988 Nov CAHN

>A> @ EQ 150MG BASE A071676 001 Jan 05, 1988 Nov CAHN

CREAM; TOPICAL ZONALON

+ FOUGERA PHARMS 5% N020126 001 Apr 01, 1994 Jan CAHN

DOXORUBICIN HYDROCHLORIDE

INJECTABLE; INJECTION DOXORUBICIN HYDROCHLORIDE

AP ALVOGEN INC 2MG/ML A065515 001 Nov 08, 2012 Oct NEWA

AP

AP

ONCO THERAPIES LTD 2MG/ML

SANDOZ INC 2MG/ML

A200901

A200146

001

001

Feb 14, 2012

Jul 18, 2012

Jan

Jul

NEWA

NEWA

AP SUN PHARM INDS 2MG/ML A091418 001 Feb 15, 2012 Jan NEWA

INJECTABLE, LIPOSOMAL; INJECTION DOXIL

+ JANSSEN R AND D 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995 Jan CAHN

+ 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000 Jan CAHN

DOXYCYCLINE

CAPSULE; ORAL DOXYCYCLINE

AB MYLAN PHARMS INC EQ 150MG BASE A202778 001 Jun 08, 2012 May NEWA

@ SANDOZ INC EQ 50MG BASE A065032 001 Jun 30, 2000 Mar DISC

@ EQ 100MG BASE A065032 002 Jun 30, 2000 Mar DISC

MONODOX AB AQUA PHARMS EQ 50MG BASE N050641 002 Feb 10, 1992 Jul CAHN

AB EQ 75MG BASE N050641 003 Oct 18, 2006 Jul CAHN

AB + EQ 100MG BASE N050641 001 Dec 29, 1989 Jul CAHN

TABLET; ORAL DOXYCYCLINE @ SANDOZ INC EQ 50MG BASE A065353 001 Nov 27, 2006 Mar DISC

@ EQ 75MG BASE A065353 002 Nov 27, 2006 Mar DISC

@ EQ 100MG BASE A065353 003 Nov 27, 2006 Mar DISC

DOXYCYCLINE HYCLATE

INJECTABLE; INJECTION DOXYCYCLINE @ HIKMA MAPLE EQ 100MG BASE/VIAL A062450 001 Oct 27, 1983 Jul CAHN

@ EQ 200MG BASE/VIAL A062450 002 Oct 27, 1983 Jul CAHN

AP PFIZER EQ 100MG BASE/VIAL A091406 001 Aug 21, 2012 Aug NEWA

DOXYCYCLINE HYCLATE @ HIKMA MAPLE EQ 100MG BASE/VIAL

@ EQ 200MG BASE/VIAL

A062992

A062992

001

002

Feb 16, 1989

Feb 16, 1989

Jul

Jul

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 49: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-40

TABLET; ORAL DOXYCYCLINE HYCLATE

AB

AB

LARKEN LABS EQ 20MG BASE

WATSON LABS INC FL EQ 100MG BASE

TABLET, DELAYED RELEASE; ORAL DORYX

A065287

A062421

001

001

Feb 28, 2006

Feb 02, 1983

Apr

Oct

CMFD

CAHN

AB + MAYNE PHARMA

DOXYCYCLINE HYCLATE

EQ 150MG BASE N050795 003 Jun 20, 2008 Jan CTEC

AB MYLAN PHARMS INC EQ 150MG BASE A091052 001 Feb 08, 2012 Jan NEWA

DROSPIRENONE; ESTRADIOL

TABLET; ORAL ANGELIQ

BAYER HLTHCARE 0.25MG;0.5MG N021355 001 Feb 29, 2012 Feb NEWA

ECONAZOLE NITRATE

CREAM; TOPICAL ECONAZOLE NITRATE

AB + FOUGERA PHARMS 1% A076075 001 Nov 26, 2002 Jan CAHN

ELTROMBOPAG OLAMINE

TABLET; ORAL PROMACTA

>A> GLAXOSMITHKLINE EQ 100MG ACID N022291 005 Nov 16, 2012 Nov NEWA

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL COMPLERA

+ GILEAD SCIENCES INC 200MG;EQ 25MG BASE;300MG N202123 001 Aug 10, 2011 Apr CAIN

ENALAPRIL MALEATE

TABLET; ORAL ENALAPRIL MALEATE @ SANDOZ INC

@

@

@

@

@

@

@

2.5MG

2.5MG

5MG

5MG

10MG

10MG

20MG

20MG

A075621

A075496

A075621

A075496

A075621

A075459

A075621

A075459

001

001

002

002

003

001

004

002

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Feb

Jan

Feb

Jan

Feb

Jan

Feb

Jan

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE @ SANDOZ INC

@

5MG;12.5MG

10MG;25MG

A076116

A076116

001

002

Sep 19, 2001

Sep 19, 2001

Mar

Mar

DISC

DISC

ENFLURANE

LIQUID; INHALATION ETHRANE

AN + BAXTER HLTHCARE 99.9% N017087 001 Jul CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 50: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-41

ENTACAPONE

AB

AB

AB

TABLET; ORAL COMTAN

+ ORION PHARMA

+

ENTACAPONE SUN PHARMA GLOBAL

WOCKHARDT LTD

200MG

200MG

200MG

200MG

N020796

N020796

A090690

A078941

001

001

001

001

Oct 19, 1999

Oct 19, 1999

Jul 16, 2012

Aug 16, 2012

Jul

May

Jul

Jul

CFTG

CAHN

NEWA

NEWA

ENZALUTAMIDE

CAPSULE; ORAL XTANDI

+ ASTELLAS

+ MEDIVATION

40MG

40MG

N203415

N203415

001

001

Aug 31, 2012

Aug 31, 2012

Sep

Aug

CAHN

NEWA

EPINASTINE HYDROCHLORIDE

AT

SOLUTION/DROPS; OPHTHALMICEPINASTINE HYDROCHLORIDE

LUITPOLD 0.05% A090951 001 Oct 31, 2011 Mar CAHN

EPINEPHRINE

>D>

>D>

>A>

>A>

BX

BX

BX

BX

BX

BX

BX

BX

BX

BX

INJECTABLE; IM-SC ADRENACLICK

+ COREPHARMA

+

AUVI-Q + INTELLIJECT

+

+ SANOFI AVENTIS US

TWINJECT 0.15 + COREPHARMA

TWINJECT 0.3 + COREPHARMA

EQ 0.15MG/DELIVERY

EQ 0.3MG/DELIVERY

EQ 0.15MG/DELIVERY

EQ 0.15MG/DELIVERY

EQ 0.3MG/DELIVERY

EQ 0.3MG/DELIVERY

EQ 0.15MG/DELIVERY

EQ 0.3MG/DELIVERY

EQ 0.15MG/DELIVERY

EQ 0.3MG/DELIVERY

N020800

N020800

N201739

N201739

N201739

N201739

N201739

N201739

N020800

N020800

003

004

002

002

001

001

002

001

002

001

Nov 25, 2009

Nov 25, 2009

Aug 10, 2012

Aug 10, 2012

Aug 10, 2012

Aug 10, 2012

Aug 10, 2012

Aug 10, 2012

May 28, 2004

May 30, 2003

Mar

Mar

Nov

Aug

Nov

Aug

Nov

Nov

Mar

Mar

CAHN

CAHN

CAHN

NEWA

CAHN

NEWA

CAHN

CAHN

CAHN

CAHN

AP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE @ HIKMA MAPLE 0.01MG/ML;1%

@ 0.01MG/ML;2%

OCTOCAINE + SEPTODONT 0.01MG/ML;2%

XYLOCAINE DENTAL WITH EPINEPHRINE @ DENTSPLY PHARM 0.01MG/ML;2%

@ 0.02MG/ML;2%

A080406

A080406

A084048

N021381

N021381

001

002

001

001

002

Sep

Sep

May

May

May

CAHN

CAHN

CRLD

DISC

DISC

EPIRUBICIN HYDROCHLORIDE

AP

AP

AP

AP

INJECTABLE; INJECTION EPIRUBICIN HYDROCHLORIDE

CIPLA LTD 200MG/100ML (2MG/ML)

50MG/25ML (2MG/ML)

HISUN PHARM HANGZHOU 50MG/25ML (2MG/ML)

200MG/100ML (2MG/ML)

A065361

A065361

A090075

A090075

002

001

001

002

Oct 22, 2007

Oct 22, 2007

Mar 25, 2010

Mar 25, 2010

Mar

Mar

Mar

Mar

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 51: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-42

INJECTABLE; INJECTION EPIRUBICIN HYDROCHLORIDE

AP

AP

ONCO THERAPIES LTD 50MG/25ML (2MG/ML)

200MG/100ML (2MG/ML)

A091599

A091599

001

002

Mar 12, 2012

Mar 12, 2012

Mar

Mar

NEWA

NEWA

EPOPROSTENOL SODIUM

INJECTABLE; INJECTION VELETRI

+

ACTELION PHARMS LTD EQ 0.5MG BASE/VIAL

EQ 1.5MG BASE/VIAL

N022260

N022260

002

001

Jun 28, 2012

Jun 27, 2008

Jun

May

NEWA

CAHN

ERYTHROMYCIN

CAPSULE, DELAYED REL PELLETS; ORAL ERYC

AB WARNER CHILCOTT LLC 250MG A062338 001 Jun CAHN

GEL; TOPICAL E-GLADES @ COREPHARMA 2% A065009 001 Mar 18, 2002 Jul DISC

@ RENAISSANCE PHARMA 2% A065009 001 Mar 18, 2002 Aug CAHN

ERYTHROMYCIN AT FOUGERA PHARMS 2% A064184 001 Sep 30, 1997 Jan CAHN

SOLUTION; TOPICAL C-SOLVE-2

AT FOUGERA PHARMS 2% A062468 001 Jul 03, 1985 Jan CMFD

ERYTHROMYCIN @ RENAISSANCE PHARMA 2% A064127 001 Feb 14, 1997 Aug CAHN

SWAB; TOPICAL ERYCETTE @ JOHNSON AND JOHNSON 2% N050594 001 Feb 15, 1985 Apr CAHN

ERYTHROMYCIN AT + FOUGERA PHARMS 2% A065320 001 Jul 25, 2006 Jan CAHN

@ RENAISSANCE PHARMA 2% A064128 001 Jul 03, 1996 Sep CAHN

ESCITALOPRAM OXALATE

SOLUTION; ORAL ESCITALOPRAM OXALATE

AA

AA

AMNEAL PHARMS

AUROBINDO PHARMA LTD

EQ 5MG BASE/5ML

EQ 5MG BASE/5ML

A202227

A079062

001

001

Mar 14, 2012

Apr 02, 2012

Feb

Mar

NEWA

NEWA

AA HETERO LABS LTD III EQ 5MG BASE/5ML A202221 001 Jun 12, 2012 May NEWA

AA TARO EQ 5MG BASE/5ML A079121 001 May 03, 2012 Apr NEWA

LEXAPRO AA + FOREST LABS EQ 5MG BASE/5ML N021365 001 Nov 27, 2002 Feb CFTG

TABLET; ORAL ESCITALOPRAM OXALATE

AB ACCORD HLTHCARE EQ 5MG BASE A202389 001 Sep 11, 2012 Aug NEWA

AB EQ 10MG BASE A202389 002 Sep 11, 2012 Aug NEWA

AB

AB

AB

APOTEX INC

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

A202389

A078777

A078777

003

001

002

Sep 11, 2012

Sep 11, 2012

Sep 11, 2012

Aug

Aug

Aug

NEWA

NEWA

NEWA

AB EQ 20MG BASE A078777 003 Sep 11, 2012 Aug NEWA

AB AUROBINDO PHARMA LTD EQ 5MG BASE A090432 001 Sep 11, 2012 Aug NEWA

AB EQ 10MG BASE A090432 002 Sep 11, 2012 Aug NEWA

AB EQ 20MG BASE A090432 003 Sep 11, 2012 Aug NEWA

AB

AB

HIKMA PHARMS EQ 5MG BASE

EQ 10MG BASE

A078766

A078766

001

002

Sep 11, 2012

Sep 11, 2012

Aug

Aug

NEWA

NEWA

AB EQ 20MG BASE A078766 003 Sep 11, 2012 Aug NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 52: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-43

TABLET; ORAL ESCITALOPRAM OXALATE

AB

AB

AB

AB

INVAGEN PHARMS

IVAX SUB TEVA PHARMS

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

A078604

A078604

A078604

A076765

001

002

003

001

Sep 11, 2012

Sep 11, 2012

Sep 11, 2012

Mar 14, 2012

Aug

Aug

Aug

Feb

NEWA

NEWA

NEWA

NEWA

AB EQ 10MG BASE A076765 002 Mar 14, 2012 Feb NEWA

AB EQ 20MG BASE A076765 003 Mar 14, 2012 Feb NEWA

AB

AB

AB

AB

AB

JUBILANT ORGANOSYS

LUPIN LTD

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

A202280

A202280

A202280

A078169

A078169

001

002

003

001

002

Sep 12, 2012

Sep 12, 2012

Sep 12, 2012

Sep 11, 2012

Sep 11, 2012

Aug

Aug

Aug

Aug

Aug

NEWA

NEWA

NEWA

NEWA

NEWA

AB EQ 20MG BASE A078169 003 Sep 11, 2012 Aug NEWA

AB MACLEODS PHARMS LTD EQ 5MG BASE A202210 001 Sep 11, 2012 Aug NEWA

AB

AB

AB

AB

AB

STI PHARMA LLC

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

A202210

A202210

A077512

A077512

A077512

002

003

001

002

003

Sep 11, 2012

Sep 11, 2012

Sep 12, 2012

Sep 12, 2012

Sep 12, 2012

Aug

Aug

Aug

Aug

Aug

NEWA

NEWA

NEWA

NEWA

NEWA

AB TORRENT PHARMS LTD EQ 5MG BASE A090939 001 Sep 11, 2012 Aug NEWA

AB EQ 10MG BASE A090939 002 Sep 11, 2012 Aug NEWA

AB

AB

AB

AB

ZYDUS PHARMS USA INC

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

A090939

A077734

A077734

A077734

003

001

002

003

Sep 11, 2012

Sep 11, 2012

Sep 11, 2012

Sep 11, 2012

Aug

Aug

Aug

Aug

NEWA

NEWA

NEWA

NEWA

LEXAPRO AB FOREST LABS EQ 5MG BASE N021323 001 Aug 14, 2002 Feb CFTG

AB EQ 10MG BASE N021323 002 Aug 14, 2002 Feb CFTG

AB + EQ 20MG BASE N021323 003 Aug 14, 2002 Feb CFTG

ESMOLOL HYDROCHLORIDE

INJECTABLE; INJECTION BREVIBLOC @ BAXTER HLTHCARE 10MG/ML N019386 003 Aug 15, 1988 Jun CAHN

AP + 10MG/ML N019386 006 Feb 25, 2003 Jun CAHN

@ 20MG/ML N019386 007 May 28, 2003 Jun CAHN

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER + BAXTER HLTHCARE 2GM/100ML N019386 005 Jan 27, 2003 Jun CAHN

BREVIBLOC IN PLASTIC CONTAINER + BAXTER HLTHCARE 1GM/100ML N019386 004 Feb 16, 2001 Jun CAHN

ESOMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE; ORAL NEXIUM

ASTRAZENECA EQ 2.5MG BASE/PACKET N021957 003 Dec 15, 2011 Jun NEWA

EQ 5MG BASE/PACKET N021957 004 Dec 15, 2011 Jun NEWA

ESTRADIOL

CREAM; VAGINAL ESTRACE

+ WARNER CHILCOTT US 0.01% A086069 001 Jan 31, 1984 Jun CAHN

FILM, EXTENDED RELEASE; TRANSDERMAL MINIVELLE

NOVEN 0.0375MG/24HR N203752 001 Oct 29, 2012 Oct NEWA

0.05MG/24HR N203752 003 Oct 29, 2012 Oct NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 53: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-44

FILM, EXTENDED RELEASE; TRANSDERMAL MINIVELLE

+

NOVEN 0.075MG/24HR

0.1MG/24HR

N203752

N203752

002

004

Oct 29, 2012

Oct 29, 2012

Oct

Oct

NEWA

NEWA

GEL, METERED; TRANSDERMAL ELESTRIN

+ JAZZ PHARMS COMMERCL 0.06% (0.87GM/ACTIVATION) N021813 001 Dec 15, 2006 Jun CAHN

+

+

JAZZ PHARMS II

MEDA PHARMS

0.06% (0.87GM/ACTIVATION)

0.06% (0.87GM/ACTIVATION)

N021813

N021813

001

001

Dec 15, 2006

Dec 15, 2006

Sep

Oct

CAHN

CAHN

ESTRADIOL ACETATE

INSERT, EXTENDED RELEASE; VAGINAL FEMRING

WARNER IRELAND EQ 0.05MG BASE/24HR N021367 001 Mar 20, 2003 May CAHN

+ EQ 0.1MG BASE/24HR N021367 002 Mar 20, 2003 May CAHN

TABLET; ORAL FEMTRACE

WARNER CHILCOTT LLC 0.45MG N021633 001 Aug 20, 2004 Jun CAHN

0.9MG N021633 002 Aug 20, 2004 Jun CAHN

+ 1.8MG N021633 003 Aug 20, 2004 Jun CAHN

ESTRADIOL; NORETHINDRONE ACETATE

TABLET; ORAL ESTRADIOL AND NORETHINDRONE ACETATE

AB TEVA PHARMS USA 0.5MG;0.1MG A200747 001 Mar 08, 2012 Feb NEWA

ESTROGENS, CONJUGATED SYNTHETIC A

TABLET; ORAL CENESTIN

TEVA BRANDED PHARM 0.3MG N020992 001 Jun 21, 2002 Jun CAHN

0.45MG N020992 005 Feb 05, 2004 Jun CAHN

0.625MG N020992 002 Mar 24, 1999 Jun CAHN

0.9MG N020992 003 Mar 24, 1999 Jun CAHN

+ 1.25MG N020992 004 Mar 13, 2000 Jun CAHN

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL LEVONORGESTREL AND ETHINYL ESTRADIOL

AB LUPIN LTD 0.03MG;0.15MG A091440 001 Oct 23, 2012 Oct NEWA

+ WATSON LABS 0.02MG;0.09MG A079218 001 Jun 06, 2011 May CRLD

LOSEASONIQUE AB TEVA BRANDED PHARM 0.02MG,0.01MG;0.1MG,N/A N022262 001 Oct 24, 2008 Jun CAHN

LYBREL @ WYETH PHARMS INC 0.02MG;0.09MG N021864 001 May 22, 2007 May DISC

PREVEN EMERGENCY CONTRACEPTIVE KIT @ TEVA BRANDED PHARM 0.05MG;0.25MG N020946 001 Sep 01, 1998 Jun CAHN

SEASONALE AB + TEVA BRANDED PHARM 0.03MG;0.15MG N021544 001 Sep 05, 2003 Jul CAHN

SEASONIQUE AB + TEVA BRANDED PHARM 0.03MG,0.01MG;0.15MG,N/A N021840 001 May 25, 2006 Jun CAHN

TABLET; ORAL-21 NORDETTE-21 @ TEVA BRANDED PHARM 0.03MG;0.15MG N018668 001 May 10, 1982 Jun CAHN

TABLET; ORAL-28 FALMINA

AB1 NOVAST LABS LTD 0.02MG;0.1MG A090721 001 Mar 28, 2012 Mar NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 54: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-45

TABLET; ORAL-28 KURVELO

AB LUPIN LTD 0.03MG;0.15MG A091408 001 Oct 17, 2012 Oct NEWA

MARLISSA AB GLENMARK GENERICS 0.03MG;0.15MG A091452 001 Feb 29, 2012 Feb NEWA

MYZILRA AB VINTAGE PHARMS 0.03MG,0.04MG,0.03MG;0.05MG,0.075

MG,0.125MG A077502 001 Nov 23, 2011 May CDFR

AB VINTAGE PHARMS LLC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

A077502 001 Nov 23, 2011 Sep CAHN

NORDETTE-28 AB + TEVA BRANDED PHARM 0.03MG;0.15MG N018782 001 Jul 21, 1982 Jun CAHN

ORSYTHIA AB1 VINTAGE PHARMS LLC 0.02MG;0.1MG A077099 001 May 11, 2011 Sep CAHN

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE; TRANSDERMAL ORTHO EVRA

+ JANSSEN PHARMS 0.75MG;6MG N021180 001 Nov 20, 2001 Jun CPOT

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET; ORAL-28

AB ALYACEN 1/35

GLENMARK GENERICS 0.035MG;1MG A091634 001 Jan 19, 2012 Jan NEWA

AB ALYACEN 7/7/7

GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

A091636 001 Jan 19, 2012 Jan NEWA

AB CYCLAFEM 1/35

VINTAGE PHARMS LLC 0.035MG;1MG A076337 001 Nov 12, 2010 Sep CAHN

AB CYCLAFEM 7/7/7

VINTAGE PHARMS LLC 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

A076338 001 Nov 16, 2010 Sep CAHN

>A> GILDAGIA >A> AB VINTAGE PHARMS 0.035MG;0.4MG A078376 001 Nov 06, 2012 Nov CTNA

>D> NORETHINDRONE AND ETHINYL ESTRADIOL >D> AB VINTAGE PHARMS 0.035MG;0.4MG A078376 001 Nov 06, 2012 Nov CTNA

AB 0.035MG;0.4MG A078376 001 Nov 06, 2012 Oct NEWA

OVCON-35 AB + WARNER CHILCOTT LLC 0.035MG;0.4MG N017716 001 Jun CAHN

OVCON-50 + WARNER CHILCOTT LLC 0.05MG;1MG N017576 001 Jun CAHN

WERA AB NOVAST LABS LTD 0.035MG;0.5MG A091204 001 Mar 27, 2012 Mar NEWA

TABLET, CHEWABLE; ORAL FEMCON FE

AB + WARNER CHILCOTT LLC 0.035MG;0.4MG N021490 001 Nov 14, 2003 Jun CAHN

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET; ORAL FEMHRT

WARNER CHILCOTT LLC 0.0025MG;0.5MG N021065 001 Jan 14, 2005 Jun CAHN

AB + 0.005MG;1MG N021065 002 Oct 15, 1999 Jun CAHN

LO LOESTRIN FE + WARNER CHILCOTT LLC 0.01MG,0.01MG;1MG,N/A N022501 001 Oct 21, 2010 Jun CAHN

TABLET; ORAL-21 ESTROSTEP 21 @ WARNER CHILCOTT LLC 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N020130 001 Oct 09, 1996 Jun CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 55: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-46

AB

AB

TABLET; ORAL-21 LOESTRIN 21 1.5/30

WARNER CHILCOTT LLC

LOESTRIN 21 1/20WARNER CHILCOTT LLC

TABLET; ORAL-28 ESTROSTEP FE

0.03MG;1.5MG

0.02MG;1MG

N017875

N017876

001

001

Jun

Jun

CAHN

CAHN

AB

AB

AB

AB

+

+

WARNER CHILCOTT LLC

GILDESS FE 1.5/30VINTAGE PHARMS LLC

GILDESS FE 1/20VINTAGE PHARMS LLC

LOESTRIN FE 1.5/30WARNER CHILCOTT LLC

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

0.03MG;1.5MG

0.02MG;1MG

0.03MG;1.5MG

N020130

A077075

A077077

N017355

002

001

001

001

Oct 09, 1996

Apr 28, 2005

May 20, 2005

Jun

Sep

Sep

Jun

CAHN

CAHN

CAHN

CAHN

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET; ORAL-28 MONO-LINYAH

AB NOVAST LABS LTD 0.035MG;0.25MG

NORGESTIMATE AND ETHINYL ESTRADIOL

A090523 001 May 23, 2012 May NEWA

AB

AB

GLENMARK GENERICS

LUPIN PHARMS

PREVIFEM

0.035MG;0.25MG

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

A200538

A200541

001

001

Apr 05, 2012

Jun 25, 2012

Mar

Jun

NEWA

NEWA

AB VINTAGE PHARMS LLC

TRI-LINYAH

0.035MG;0.25MG A076334 001 Jan 09, 2004 Sep CAHN

AB NOVAST LABS LTD

TRI-PREVIFEM

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

A090524 001 May 30, 2012 May NEWA

AB VINTAGE PHARMS LLC 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

A076335 001 Mar 26, 2004 Sep CAHN

ETHINYL ESTRADIOL; NORGESTREL

TABLET; ORAL-28 ELINEST

AB NOVAST LABS LTD 0.03MG;0.3MG A091105 001 Mar 28, 2012 Mar NEWA

ETHOSUXIMIDE

CAPSULE; ORAL ETHOSUXIMIDE

AB ZYDUS PHARMS USA INC 250MG A200892 001 Sep 25, 2012 Sep NEWA

ETHOTOIN

TABLET; ORAL PEGANONE

+

@

LUNDBECK LLC 250MG

500MG

N010841

N010841

001

003

Aug

Aug

CAHN

CAHN

ETODOLAC

CAPSULE; ORAL ETODOLAC @ VINTAGE PHARMS LLC

@

TABLET; ORAL ETODOLAC

200MG

300MG

A074842

A074842

001

002

Jul 17, 1997

Jul 17, 1997

Sep

Sep

CAHN

CAHN

AB

AB

PROSAM LABS 400MG

500MG

A074819

A074819

001

002

Feb 28, 1997

Apr 28, 1998

Feb

Feb

CMFD

CMFD

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 56: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-47

TABLET; ORAL ETODOLAC @ VINTAGE PHARMS LLC 400MG

TABLET, EXTENDED RELEASE; ORAL ETODOLAC

A074841 001 Jun 27, 1997 Sep CAHN

@ ACTAVIS ELIZABETH 400MG A075696 001 Jul 31, 2000 Oct CAHN

ETOMIDATE

AP

INJECTABLE; INJECTION ETOMIDATE

MYLAN INSTITUTIONAL 2MG/ML A091297 001 Jun 20, 2012 Jun NEWA

ETOPOSIDE

CAPSULE; ORAL VEPESID @ CORDEN PHARMA

@

INJECTABLE; INJECTION ETOPOSIDE

50MG

100MG

N019557

N019557

001

002

Dec 30, 1986

Dec 30, 1986

Feb

Feb

CAHN

CAHN

AP

AP

+ APP PHARMS LLC

BEDFORD

VEPESID

20MG/ML

20MG/ML

A074983

A074290

001

001

Sep 30, 1998

Jul 17, 1995

Mar

Mar

CRLD

CRLD

@ CORDEN PHARMA 20MG/ML N018768 001 Nov 10, 1983 Feb CAHN

ETRAVIRINE

TABLET; ORAL INTELENCE

JANSSEN R AND D

+

25MG

100MG

200MG

N022187

N022187

N022187

003

001

002

Mar 26, 2012

Jan 18, 2008

Dec 22, 2010

Mar

Feb

Feb

NEWA

CAHN

CAHN

EVEROLIMUS

TABLET; ORAL AFINITOR

NOVARTIS 7.5MG

TABLET, FOR SUSPENSION; ORAL AFINITOR DISPERZ

N022334 004 Mar 30, 2012 Apr NEWA

+

NOVARTIS PHARM 2MG

3MG

5MG

N203985

N203985

N203985

001

002

003

Aug 29, 2012

Aug 29, 2012

Aug 29, 2012

Aug

Aug

Aug

NEWA

NEWA

NEWA

EXENATIDE SYNTHETIC

FOR SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS BYDUREON

+ AMYLIN 2MG/VIAL N022200 001 Jan 27, 2012 Jan NEWA

EZETIMIBE

TABLET; ORAL ZETIA

+

+

MSD INTL GMBH

MSP SINGAPORE

10MG

10MG

N021445

N021445

001

001

Oct 25, 2002

Oct 25, 2002

Feb

Jan

CAHN

CAHN

EZETIMIBE; SIMVASTATIN

TABLET; ORAL VYTORIN

MSD INTL 10MG;10MG N021687 001 Jul 23, 2004 Jan CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 57: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-48

TABLET; ORAL VYTORIN

+

MSD INTL 10MG;20MG

10MG;40MG

10MG;80MG

N021687

N021687

N021687

002

003

004

Jul 23, 2004

Jul 23, 2004

Jul 23, 2004

Jan

Jan

Jan

CAHN

CAHN

CAHN

EZOGABINE

TABLET; ORAL POTIGA

+

GLAXOSMITHKLINE 50MG

200MG

300MG

400MG

N022345

N022345

N022345

N022345

001

002

003

004

Jun 10, 2011

Jun 10, 2011

Jun 10, 2011

Jun 10, 2011

May

May

May

May

CAHN

CAHN

CAHN

CAHN

FAMCICLOVIR

TABLET; ORAL FAMCICLOVIR

AB

AB

AB

MACLEODS PHARMS LTD 125MG

250MG

500MG

A201022

A201022

A201022

001

002

003

Jan 12, 2012

Jan 12, 2012

Jan 12, 2012

Jan

Jan

Jan

NEWA

NEWA

NEWA

FAMOTIDINE

INJECTABLE; INJECTION FAMOTIDINE

AP

AP

+

+

HIKMA MAPLE 10MG/ML

10MG/ML

FAMOTIDINE PRESERVATIVE FREE

A075799

A075488

001

001

Apr 30, 2002

Apr 16, 2001

Jul

Jul

CAHN

CAHN

AP

AP

+ HIKMA MAPLE

+

TABLET; ORAL FAMOTIDINE

10MG/ML

10MG/ML

A075486

A075789

001

001

Apr 16, 2001

Apr 30, 2002

Jul

Jul

CAHN

CAHN

@ MYLAN PHARMS INC

@

@ SANDOZ

@

PEPCID

20MG

40MG

20MG

40MG

A075457

A075457

A075607

A075607

001

002

001

002

Apr 18, 2001

Apr 18, 2001

May 10, 2001

May 10, 2001

Oct

Oct

Oct

Oct

DISC

DISC

DISC

DISC

AB

AB +

MARATHON PHARMS 20MG

40MG

N019462

N019462

001

002

Oct 15, 1986

Oct 15, 1986

Jan

Jan

CAHN

CAHN

TABLET, ORALLY DISINTEGRATING; ORAL FLUXID @ UCB INC

@

20MG

40MG

N021712

N021712

001

002

Sep 24, 2004

Sep 24, 2004

Jan

Jan

CAHN

CAHN

FEBUXOSTAT

TABLET; ORAL ULORIC

+

TAKEDA PHARMS USA 40MG

80MG

N021856

N021856

001

002

Feb 13, 2009

Feb 13, 2009

Apr

Apr

CAHN

CAHN

FELODIPINE

TABLET, EXTENDED RELEASE; ORAL FELODIPINE

AB

AB

AB

AB

VINTAGE PHARMS LLC

WOCKHARDT LTD

2.5MG

5MG

10MG

2.5MG

A200815

A200815

A200815

A091484

001

002

003

001

Oct 28, 2011

Oct 28, 2011

Oct 28, 2011

Aug 15, 2012

Sep

Sep

Sep

Jul

CAHN

CAHN

CAHN

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 58: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-49

TABLET, EXTENDED RELEASE; ORAL FELODIPINE

AB WOCKHARDT LTD 5MG A091484 002 Aug 15, 2012 Jul NEWA

AB 10MG A091484 003 Aug 15, 2012 Jul NEWA

FENOFIBRATE

CAPSULE; ORAL

AB ANTARA (MICRONIZED)

LUPIN ATLANTIS 43MG N021695 001 Nov 30, 2004 Feb CFTG

AB + 130MG N021695 003 Nov 30, 2004 Feb CFTG

AB FENOFIBRATE (MICRONIZED)

DR REDDYS LABS SA 43MG A090859 001 Mar 01, 2012 Feb NEWA

AB 130MG A090859 002 Mar 01, 2012 Feb NEWA

AB MYLAN PHARMS INC 67MG A202676 001 Oct 23, 2012 Oct NEWA

AB 134MG A202676 002 Oct 23, 2012 Oct NEWA

AB 200MG A202676 003 Oct 23, 2012 Oct NEWA

TABLET; ORAL FENOFIBRATE

AB IMPAX LABS 160MG A076509 002 Mar 26, 2008 May CRLD

AB + 160MG A076509 002 Mar 26, 2008 Mar CRLD

>A> AB MYLAN PHARMS INC 48MG A202856 001 Dec 07, 2012 Nov NEWA

>A> AB 145MG A202856 002 Dec 07, 2012 Nov NEWA

AB TEVA 54MG

@ 54MG

A076433

A076433

001

001

May 13, 2005

May 13, 2005

May

Mar

CMFD

DISC

AB + 160MG

@ 160MG

A076433

A076433

002

002

May 13, 2005

May 13, 2005

May

Mar

CMFD

DISC

AB VALEANT INTL 48MG A090715 001 Apr 05, 2012 Mar NEWA

AB 145MG A090715 002 Apr 05, 2012 Mar NEWA

FENOPROFEN CALCIUM

CAPSULE; ORAL NALFON

+ XSPIRE EQ 200MG BASE N017604 003 Aug CAHN

@ EQ 300MG BASE N017604 002 Aug CAHN

EQ 400MG BASE N017604 004 Jul 21, 2009 Aug CAHN

FENTANYL

FILM, EXTENDED RELEASE; TRANSDERMAL FENTANYL-100

>D> AB

AB

ACTAVIS 100MCG/HR

AVEVA 100MCG/HR

A077062

A077449

004

004

Aug 20, 2007

Oct 20, 2008

Nov

Jun

CAHN

CAHN

>A> AB PAR PHARM INC 100MCG/HR A077062 004 Aug 20, 2007 Nov CAHN

FENTANYL-25 >D> AB ACTAVIS 25MCG/HR A077062 001 Aug 20, 2007 Nov CAHN

AB AVEVA 25MCG/HR A077449 001 Oct 20, 2008 Jun CAHN

>A> AB PAR PHARM INC 25MCG/HR A077062 001 Aug 20, 2007 Nov CAHN

FENTANYL-50 >D> AB ACTAVIS 50MCG/HR A077062 002 Aug 20, 2007 Nov CAHN

AB AVEVA 50MCG/HR A077449 002 Oct 20, 2008 Jun CAHN

>A> AB PAR PHARM INC 50MCG/HR A077062 002 Aug 20, 2007 Nov CAHN

FENTANYL-75 >D> AB ACTAVIS 75MCG/HR A077062 003 Aug 20, 2007 Nov CAHN

AB AVEVA 75MCG/HR A077449 003 Oct 20, 2008 Jun CAHN

>A> AB PAR PHARM INC 75MCG/HR A077062 003 Aug 20, 2007 Nov CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 59: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-50

SPRAY; SUBLINGUAL

SUBSYS INSYS THERAP 0.1MG

0.1MCG

0.2MG

0.2MCG

+ 0.4MG

+ 0.4MCG

0.6MG

0.6MCG

0.8MG

0.8MCG

FENTANYL CITRATE

SPRAY, METERED; NASAL

LAZANDA

ARCHIMEDES EQ 0.1MG BASE

+ EQ 0.4MG BASE

TROCHE/LOZENGE; TRANSMUCOSALFENTANYL CITRATE

AB PAR PHARM EQ 0.2MG BASE

AB EQ 0.4MG BASE

AB EQ 0.6MG BASE

AB EQ 0.8MG BASE

AB EQ 1.2MG BASE

AB EQ 1.6MG BASE

FERUMOXIDES

INJECTABLE; INJECTION

FERIDEX I.V. @ AMAG PHARMS INC EQ 11.2MG IRON/ML

FEXOFENADINE HYDROCHLORIDE

SUSPENSION; ORAL

ALLEGRA

AB + SANOFI AVENTIS US 30MG/5ML

FEXOFENADINE HYDROCHLORIDE AB ACTAVIS MID ATLANTIC 30MG/5ML

FLORBETAPIR F-18

SOLUTION; INTRAVENOUS

AMYVID + AVID RADIOPHARMS INC 10-50ML (13.5-51MCI/ML)

+ 10-30ML (13.5-51MCI/ML)

+ 10-50ML (13.5-51CMI/ML)

+ 10ML (13.5-51MCI/ML)

FLUCONAZOLE

INJECTABLE; INJECTION FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP AGILA SPECLTS 200MG/100ML (2MG/ML)

AP 400MG/200ML (2MG/ML)

AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML)

AP 400MG/200ML (2MG/ML)

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER @ AGILA SPECLTS 200MG/100ML (2MG/ML)

N202788

N202788

N202788

N202788

N202788

N202788

N202788

N202788

N202788

N202788

N022569

N022569

A077312

A077312

A077312

A077312

A077312

A077312

N020416

N021963

A201311

N202008

N202008

N202008

N202008

A076888

A076888

A078764

A078764

A076889

001

001

002

002

003

003

004

004

005

005

001

002

001

002

003

004

005

006

001

001

001

003

002

003

001

001

002

001

002

001

MarJan 04, 2012 CPOT

JanJan 04, 2012 NEWA

MarJan 04, 2012 CPOT

JanJan 04, 2012 NEWA

MarJan 04, 2012 CPOT

JanJan 04, 2012 NEWA

MarJan 04, 2012 CPOT

JanJan 04, 2012 NEWA

MarJan 04, 2012 CPOT

JanJan 04, 2012 NEWA

JanJun 30, 2011 CPOT

JanJun 30, 2011 CPOT

FebOct 30, 2009 CAHN

FebOct 30, 2009 CAHN

FebOct 30, 2009 CAHN

FebOct 30, 2009 CAHN

FebOct 30, 2009 CAHN

FebOct 30, 2009 CAHN

JunAug 30, 1996 DISC

JulOct 16, 2006 CFTG

JulJul 25, 2012 NEWA

JunApr 06, 2012 CPOT

AprApr 06, 2012

AprApr 06, 2012

AprApr 06, 2012

NEWA

NEWA

NEWA

AugMar 25, 2005

AugMar 25, 2005

CAHN

CAHN

JanJan 30, 2012 NEWA

JanJan 30, 2012 NEWA

AugMar 25, 2005 CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 60: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-51

INJECTABLE; INJECTION FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER @ AGILA SPECLTS 400MG/200ML (2MG/ML) A076889 002 Mar 25, 2005 Aug CAHN

AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A078698 001 Jan 30, 2012 Jan NEWA

AP 400MG/200ML (2MG/ML) A078698 002 Jan 30, 2012 Jan NEWA

AP TEVA PHARMS 200MG/100ML (2MG/ML) A076837 001 Jan 13, 2005 Oct CAHN

AP 400MG/200ML (2MG/ML) A076837 002 Jan 13, 2005 Oct CAHN

TABLET; ORAL FLUCONAZOLE

AB HARRIS PHARM 50MG A078423 001 Mar 07, 2011 Jul CAHN

AB 100MG A078423 002 Mar 07, 2011 Jul CAHN

AB 150MG A078423 003 Mar 07, 2011 Jul CAHN

AB 200MG A078423 004 Mar 07, 2011 Jul CAHN

@ MYLAN PHARMS INC 50MG A076042 001 Jul 29, 2004 Oct DISC

@ 100MG A076042 002 Jul 29, 2004 Oct DISC

@ 150MG A076042 003 Jul 29, 2004 Oct DISC

@ 200MG A076042 004 Jul 29, 2004 Oct DISC

@ PLIVA 50MG A076424 001 Jul 29, 2004 Feb DISC

@ 100MG A076424 002 Jul 29, 2004 Feb DISC

@ 150MG A076424 003 Jul 29, 2004 Feb DISC

@ 200MG A076424 004 Jul 29, 2004 Feb DISC

@ RANBAXY LABS LTD 50MG A076386 001 Jul 29, 2004 Apr DISC

@ 100MG A076386 002 Jul 29, 2004 Apr DISC

@ 150MG A076386 003 Jul 29, 2004 Apr DISC

@ 200MG A076386 004 Jul 29, 2004 Apr DISC

FLUDARABINE PHOSPHATE

INJECTABLE; INJECTION FLUDARA @ GENZYME CORP 50MG/VIAL N020038 001 Apr 18, 1991 Mar DISC

FLUDARABINE PHOSPHATE AP + HOSPIRA 50MG/VIAL A077790 001 Apr 06, 2007 Mar CRLD

AP ONCO THERAPIES LTD 50MG/VIAL A200648 001 Oct 16, 2012 Oct NEWA

TABLET; ORAL OFORTA @ SANOFI AVENTIS US 10MG N022273 001 Dec 18, 2008 May DISC

FLUMAZENIL

INJECTABLE; INJECTION FLUMAZENIL

AP HIKMA MAPLE 0.5MG/5ML (0.1MG/ML) A076787 002 Oct 12, 2004 Jul CAHN

AP 1MG/10ML (0.1MG/ML) A076787 001 Oct 12, 2004 Jul CAHN

AP SAGENT PHARMS 0.5MG/5ML (0.1MG/ML) A090584 001 Aug 28, 2012 Aug NEWA

AP 1MG/10ML (0.1MG/ML) A090584 002 Aug 28, 2012 Aug NEWA

@ TEVA PARENTERAL 0.5MG/5ML (0.1MG/ML) A076589 002 Oct 12, 2004 Jan DISC

@ 1MG/10ML (0.1MG/ML) A076589 001 Oct 12, 2004 Jan DISC

FLUNISOLIDE

AEROSOL, METERED; INHALATION AEROSPAN HFA

+ ACTON PHARMS EQ 78MG BASE/INH N021247 001 Jan 27, 2006 Jul CPOT

SPRAY, METERED; NASAL FLUNISOLIDE

AB HI TECH PHARMA CO 0.025MG/SPRAY A077704 001 Aug 03, 2006 Aug CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 61: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-52

FLUOCINOLONE ACETONIDE

OIL/DROPS; OTICFLUOCINOLONE ACETONIDE

AT IDENTI PHARMS INC 0.01% A091306 001 Oct 17, 2011 Jan CPOT

FLUOCINONIDE

CREAM; TOPICAL FLUOCINONIDE

AB1

AB1 +

G AND W LABS INC 0.05%

TARO 0.05%

FLUOCINONIDE EMULSIFIED BASE

A073085

N019117

001

001

Feb 14, 1992

Jun 26, 1984

Sep

Oct

CAHN

CRLD

AB2

AB2 +

FOUGERA PHARMS

@ G AND W LABS INC

TARO

LIDEX

0.05%

0.05%

0.05%

A076586

A074204

A072494

001

001

001

Jun 23, 2004

Jun 13, 1995

Jan 19, 1989

Jan

May

Oct

CAHN

CAHN

CRLD

@ MEDICIS

LIDEX-E

0.05% N016908 002 Oct DISC

@ MEDICIS

OINTMENT; TOPICAL FLUOCINONIDE

0.05% N016908 003 Oct DISC

AB FOUGERA PHARMS

SOLUTION; TOPICAL FLUOCINONIDE

0.05% A074905 001 Aug 26, 1997 Jan CAHN

AT G AND W LABS INC 0.05% A071535 001 Dec 02, 1988 Sep CAHN

FLUORESCEIN SODIUM

INJECTABLE; INTRAVENOUS AK-FLUOR 25%

AKORN EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

N022186 002 Aug 08, 2008 Oct CMFD

FLUOROURACIL

CREAM; TOPICAL CARAC

+ VALEANT INTL

FLUOROPLEX

0.5% N020985 001 Oct 27, 2000 Jul CAHN

+ AQUA PHARMS

INJECTABLE; INJECTION FLUOROURACIL

1% N016988 001 Jan CAHN

AP

AP

AP

AP

ONCO THERAPIES LTD

@ SPECTRUM PHARMS

500MG/10ML (50MG/ML)

1GM/20ML (50MG/ML)

2.5GM/50ML (50MG/ML)

5GM/100ML (50MG/ML)

50MG/ML

A202668

A202668

A202669

A202669

A087792

001

002

001

002

001

Jul 17, 2012

Jul 17, 2012

Jul 17, 2012

Jul 17, 2012

Oct 13, 1982

Jul

Jul

Jul

Jul

Sep

NEWA

NEWA

NEWA

NEWA

CAHN

FLUOXETINE HYDROCHLORIDE

CAPSULE; ORAL FLUOXETINE HYDROCHLORIDE

AB1

AB1

AB

AB1

AB1

HERITAGE PHARMS INC

MYLAN PHARMS INC

PROZAC

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 10MG BASE

EQ 20MG BASE

A201336

A201336

A201336

A075577

A075577

001

002

003

001

002

Oct 01, 2012

Oct 01, 2012

Oct 01, 2012

Jan 29, 2002

Jan 29, 2002

Sep

Sep

Sep

Sep

Sep

NEWA

NEWA

NEWA

CAHN

CAHN

AB1 ELI LILLY AND CO EQ 10MG BASE N018936 006 Dec 23, 1992 Apr CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 62: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-53

CAPSULE; ORAL PROZAC

AB1

AB +

@

ELI LILLY AND CO EQ 20MG BASE

EQ 40MG BASE

EQ 60MG BASE

N018936

N018936

N018936

001

003

004

Dec 29, 1987

Jun 15, 1999

Jun 15, 1999

Apr

Apr

Apr

CAHN

CAHN

CAHN

SARAFEM AB2 ELI LILLY AND CO EQ 10MG BASE N018936 007 Jul 06, 2000 Apr CAHN

AB2 + EQ 20MG BASE N018936 008 Jul 06, 2000 Apr CAHN

TABLET; ORAL SARAFEM

WARNER CHILCOTT LLC EQ 10MG BASE N021860 001 May 19, 2006 Jun CAHN

+

EQ 15MG BASE

EQ 20MG BASE

N021860

N021860

002

003

May 19, 2006

May 19, 2006

Jun

Jun

CAHN

CAHN

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

CAPSULE; ORAL OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

AB PAR PHARM EQ 25MG BASE;EQ 3MG BASE A077742 001 Nov 02, 2012 Oct NEWA

AB EQ 25MG BASE;EQ 6MG BASE A077742 002 Nov 02, 2012 Oct NEWA

AB EQ 25MG BASE;EQ 12MG BASE A077742 003 Nov 02, 2012 Oct NEWA

AB EQ 50MG BASE;EQ 6MG BASE A077742 004 Nov 02, 2012 Oct NEWA

AB EQ 50MG BASE;EQ 12MG BASE A077742 005 Nov 02, 2012 Oct NEWA

>A> AB SANDOZ EQ 25MG BASE;EQ 3MG BASE A078901 005 Nov 16, 2012 Nov NEWA

>A> AB EQ 25MG BASE;EQ 6MG BASE A078901 001 Nov 16, 2012 Nov NEWA

>A> AB EQ 25MG BASE;EQ 12MG BASE A078901 003 Nov 16, 2012 Nov NEWA

>A> AB EQ 50MG BASE;EQ 6MG BASE A078901 002 Nov 16, 2012 Nov NEWA

>A> AB EQ 50MG BASE;EQ 12MG BASE A078901 004 Nov 16, 2012 Nov NEWA

AB TEVA PHARMS EQ 25MG BASE;EQ 6MG BASE A077528 001 Jun 19, 2012 Jun NEWA

AB EQ 25MG BASE;EQ 12MG BASE A077528 002 Jun 19, 2012 Jun NEWA

AB EQ 50MG BASE;EQ 6MG BASE A077528 003 Jun 19, 2012 Jun NEWA

AB EQ 50MG BASE;EQ 12MG BASE A077528 004 Jun 19, 2012 Jun NEWA

SYMBYAX AB

AB

LILLY EQ 25MG BASE;EQ 3MG BASE

EQ 25MG BASE;EQ 6MG BASE

N021520

N021520

001

002

Apr 09, 2007

Dec 24, 2003

Oct

Jun

CFTG

CFTG

AB EQ 25MG BASE;EQ 12MG BASE N021520 004 Dec 24, 2003 Jun CFTG

AB + EQ 50MG BASE;EQ 6MG BASE N021520 003 Dec 24, 2003 Jun CFTG

AB EQ 50MG BASE;EQ 12MG BASE N021520 005 Dec 24, 2003 Jun CFTG

FLURANDRENOLIDE

CREAM; TOPICAL CORDRAN SP

+ AQUA PHARMS 0.025% N012806 003 Aug CRLD

0.025% N012806 003 Jul CAHN

+ 0.05%

0.05%

N012806

N012806

002

002

Aug

Jul

CRLD

CAHN

WATSON PHARMS 0.05% N012806 002 Apr CMFD

LOTION; TOPICAL CORDRAN

+ AQUA PHARMS 0.05% N013790 001 Jul CAHN

OINTMENT; TOPICAL CORDRAN @ AQUA PHARMS 0.025% N012806 004 Jul CAHN

@ 0.05% N012806 001 Jul CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 63: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-54

FLUTAMIDE

CAPSULE; ORAL FLUTAMIDE

AB

AB

AB

+ IVAX SUB TEVA PHARMS

@ SANDOZ

SANDOZ INC

WATSON LABS INC FL

125MG

125MG

125MG

125MG

A075780

A075818

A075818

A075820

001

001

001

001

Sep 19, 2001

Sep 18, 2001

Sep 18, 2001

Sep 18, 2001

Mar

Oct

Mar

Sep

CRLD

DISC

CRLD

CAHN

FLUTICASONE PROPIONATE

CREAM; TOPICAL CUTIVATE

AB + FOUGERA PHARMS

FLUTICASONE PROPIONATE

0.05% N019958 001 Dec 18, 1990 Jan CAHN

AB FOUGERA PHARMS

@ NESHER PHARMS

OINTMENT; TOPICAL FLUTICASONE PROPIONATE

0.05%

0.05%

A076451

A076865

001

001

May 14, 2004

Sep 10, 2004

Jan

Jun

CAHN

DISC

AB FOUGERA PHARMS 0.005% A076300 001 May 14, 2004 Jan CAHN

FLUVASTATIN SODIUM

CAPSULE; ORAL FLUVASTATIN SODIUM

AB

AB

AB

AB

MYLAN PHARMS INC

TEVA PHARMS

LESCOL

EQ 20MG BASE

EQ 40MG BASE

EQ 20MG BASE

EQ 40MG BASE

A090595

A090595

A078407

A078407

001

002

001

002

Apr 11, 2012

Apr 11, 2012

Jun 12, 2012

Jun 12, 2012

Mar

Mar

May

May

NEWA

NEWA

NEWA

NEWA

AB

AB +

NOVARTIS EQ 20MG BASE

EQ 40MG BASE

N020261

N020261

001

002

Dec 31, 1993

Dec 31, 1993

Mar

Mar

CFTG

CFTG

FLUVOXAMINE MALEATE

CAPSULE, EXTENDED RELEASE; ORAL LUVOX CR

+

JAZZ PHARMS 100MG

150MG

N022033

N022033

001

002

Feb 28, 2008

Feb 28, 2008

Jun

Jun

CAHN

CAHN

FOMEPIZOLE

INJECTABLE; INJECTION FOMEPIZOLE

AP MYLAN LLC 1.5GM/1.5ML (1GM/ML) A078639 001 Mar 03, 2008 Sep CAHN

FORMOTEROL FUMARATE

SOLUTION; INHALATION PERFOROMIST

+ MYLAN SPECLT 0.02MG/2ML N022007 001 May 11, 2007 Sep CAHN

FORMOTEROL FUMARATE; MOMETASONE FUROATE

AEROSOL, METERED; INHALATION DULERA

+

+

MERCK SHARP DOHME 0.005MG/INH;0.1MG/INH

0.005MG/INH;0.2MG/INH

N022518

N022518

001

002

Jun 22, 2010

Jun 22, 2010

Jun

Jun

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 64: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-55

FOSINOPRIL SODIUM

TABLET; ORAL FOSINOPRIL SODIUM @ RANBAXY LABS LTD

@

@

MONOPRIL

10MG

20MG

40MG

001 A076580

002 A076580

003 A076580

AprApr 23, 2004

AprApr 23, 2004

AprApr 23, 2004

DISC

DISC

DISC

@ BRISTOL MYERS SQUIBB

@

@

10MG

20MG

40MG

002 N019915

003 N019915

004 N019915

MarMay 16, 1991

MarMay 16, 1991

MarMar 28, 1995

DISC

DISC

DISC

FOSINOPRIL; HYDROCHLOROTHIAZIDE

TABLET; ORAL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

AB

AB

EMCURE PHARMS INDIA 10MG;12.5MG

20MG;12.5MG

001 A079025

002 A079025

OctSep 17, 2010

OctSep 17, 2010

CAHN

CAHN

FOSPHENYTOIN SODIUM

INJECTABLE; INJECTION FOSPHENYTOIN SODIUM

AP HIKMA MAPLE

@ TEVA PARENTERAL

EQ 50MG PHENYTOIN NA/ML

EQ 50MG PHENYTOIN NA/ML

001 A077989

001 A076886

JulAug 06, 2007

MarAug 06, 2007

CAHN

DISC

FOSPROPOFOL DISODIUM

SOLUTION; INTRAVENOUS LUSEDRA @ EISAI INC 1050MG/30ML (35MG/ML) 001 N022244 JulDec 12, 2008 DISC

FUROSEMIDE

INJECTABLE; INJECTION FUROSEMIDE @ HIKMA MAPLE

@

@ HOSPIRA

10MG/ML

10MG/ML

10MG/ML

001 A071439

001 N018267

001 A070578

SepSep 14, 1990

Sep

JunJul 08, 1987

CAHN

CAHN

DISC

GABAPENTIN

SOLUTION; ORAL GABAPENTIN

AA

AA

AA

ACELLA PHARMS LLC

AMNEAL PHARMS

KIEL

TABLET; ORAL GABAPENTIN

250MG/5ML

250MG/5ML

250MG/5ML

001 A076403

001 A202024

001 A076403

JunMay 01, 2012

MarMar 23, 2012

AprMay 01, 2012

CAHN

NEWA

NEWA

AB

AB

AB

AB

INVAGEN PHARMS

MYLAN PHARMS INC

600MG

800MG

600MG

800MG

001 A202764

002 A202764

001 A090335

002 A090335

OctOct 16, 2012

OctOct 16, 2012

SepJun 01, 2010

SepJun 01, 2010

NEWA

NEWA

CAHN

CAHN

GANCICLOVIR

CAPSULE; ORAL GANCICLOVIR @ RANBAXY LABS LTD

@

250MG

500MG

001 A076457

002 A076457

AprJun 27, 2003

AprJun 27, 2003

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 65: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-56

GEMCITABINE HYDROCHLORIDE

INJECTABLE; INJECTION GEMCITABINE HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

+

+

+

EMCURE PHARMS LTD

HAMELN RDS GMBH

HOSPIRA INC

TEVA PHARMS

EQ 200MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 200MG BASE/VIAL

EQ 1GM BASE/VIAL

200MG/5.26ML (38MG/ML)

1GM/26.3ML (38MG/ML)

2GM/52.6ML (38MG/ML)

EQ 200MG BASE/VIAL

EQ 1GM BASE/VIAL

A202063

A202063

A090663

A090663

N200795

N200795

N200795

A077983

A077983

001

002

001

002

001

002

003

002

001

Sep 11, 2012

Sep 11, 2012

Sep 10, 2012

Sep 10, 2012

Aug 04, 2011

Aug 04, 2011

Aug 04, 2011

Jan 25, 2011

Jan 25, 2011

Aug

Aug

Aug

Aug

Apr

Apr

Apr

Oct

Oct

NEWA

NEWA

NEWA

NEWA

CTNA

CTNA

CTNA

CAHN

CAHN

GENTAMICIN SULFATE

INJECTABLE; INJECTION GENTAMICIN SULFATE @ HIKMA MAPLE

@

EQ 10MG BASE/ML

EQ 40MG BASE/ML

A062251

A062251

002

001

Sep

Sep

CAHN

CAHN

GLIMEPIRIDE

TABLET; ORAL GLIMEPIRIDE

AB

AB

AB

AB

AB

AB

AB

AUROBINDO PHARMA LTD

MICRO LABS USA

@ RANBAXY LABS LTD

@

@

@

1MG

2MG

4MG

1MG

2MG

3MG

4MG

6MG

8MG

1MG

2MG

4MG

8MG

A202759

A202759

A202759

A091220

A091220

A091220

A091220

A091220

A091220

A076875

A076875

A076875

A076875

001

002

003

001

002

003

004

005

006

001

002

003

004

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Jun 29, 2012

Oct 06, 2005

Oct 06, 2005

Oct 06, 2005

Oct 06, 2005

Jun

Jun

Jun

Jun

Jun

Jun

Jun

Jun

Jun

Apr

Apr

Apr

Apr

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

DISC

DISC

DISC

DISC

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET; ORAL DUETACT

+ TAKEDA PHARMS USA 2MG;30MG

4MG;30MG

N021925

N021925

001

002

Jul 28, 2006

Jul 28, 2006

Aug

Aug

CAHN

CAHN

GLIPIZIDE

TABLET; ORAL GLIPIZIDE @ VINTAGE PHARMS LLC

@

5MG

10MG

A074378

A074378

001

002

Nov 28, 1994

Nov 28, 1994

Sep

Sep

CAHN

CAHN

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL GLYBURIDE AND METFORMIN HYDROCHLORIDE

AB

AB

AB

HERITAGE PHARMS INC 1.25MG;250MG

2.5MG;500MG

5MG;500MG

A079009

A079009

A079009

001

002

003

Jun 03, 2009

Jun 03, 2009

Jun 03, 2009

Sep

Sep

Sep

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 66: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-57

GLYCOPYRROLATE

SOLUTION; ORAL CUVPOSA

+ MERZ PHARMS

TABLET; ORAL GLYCOPYRROLATE

1MG/5ML N022571 001 Jul 28, 2010 Aug CAHN

AA

AA

AA

EXCELLIUM

NEXGEN PHARMA

1MG

2MG

1.5MG

A090195

A090195

A091522

001

002

001

Sep 21, 2012

Sep 21, 2012

Mar 12, 2012

Sep

Sep

Feb

NEWA

NEWA

NEWA

GRANISETRON HYDROCHLORIDE

INJECTABLE; INJECTION GRANISETRON HYDROCHLORIDE

AP

AP

AP

AP

CIPLA LTD EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)EQ 1MG BASE/ML (EQ 1MG BASE/ML)

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

HIKMA MAPLE EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

A078262

A078258

A078258

A077177

001

001

002

001

Dec 31, 2007

Jun 30, 2008

Jun 30, 2008

Dec 31, 2007

Mar

Mar

Mar

Sep

CAHN

CAHN

CAHN

CAHN

AP + APP PHARMS LLC

@ TEVA PARENTERAL

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

A078096

A077165

001

001

Jun 30, 2008

Dec 31, 2007

Apr

Apr

CRLD

DISC

GRISEOFULVIN, MICROCRYSTALLINE

SUSPENSION; ORAL GRIFULVIN V

AB + VALEANT PHARM NORTH

TABLET; ORAL GRIFULVIN V

125MG/5ML A062483 001 Jan 26, 1984 Feb CAHN

+

@ VALEANT INTL

@

125MG

250MG

500MG

A062279

A062279

A062279

001

002

003

Jul

Jul

Jul

CAHN

CAHN

CAHN

@ VALEANT LUXEMBOURG

@

125MG

250MG

A062279

A062279

001

002

Oct

Oct

CAHN

CAHN

GRISEOFULVIN, MICROSIZE

SUSPENSION; ORAL GRIFULVIN V

AB + VALEANT PHARM NORTH

GRISEOFULVIN

125MG/5ML A062483 001 Jan 26, 1984 Oct CAIN

AB

AB

AB

AB

ACTAVIS MID ATLANTIC

IVAX SUB TEVA PHARMS

PERRIGO CO TENNESSEE

VINTAGE PHARMS

TABLET; ORAL GRIFULVIN V

125MG/5ML

125MG/5ML

125MG/5ML

125MG/5ML

A065394

A065354

A065200

A065438

001

001

001

001

Jul 06, 2007

Sep 10, 2007

Mar 02, 2005

Oct 08, 2010

Oct

Oct

Oct

Oct

CAIN

CAIN

CAIN

CAIN

AB + VALEANT LUXEMBOURG 500MG A062279 003 Oct CAHN

GRISEOFULVIN AB SIGMAPHARM LABS LLC 500MG A202482 001 Oct 22, 2012 Oct NEWA

GRISEOFULVIN, ULTRAMICROSIZE

TABLET; ORAL GRISEOFULVIN,ULTRAMICROSIZE

AB SIGMAPHARM LABS LLC 125MG A202545 001 Oct 22, 2012 Oct NEWA

AB 250MG A202545 002 Oct 22, 2012 Oct NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 67: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-58

TABLET; ORAL GRIS-PEG

AB PEDINOL 125MG N050475 001 Oct CTEC

AB + 250MG N050475 002 Oct CTEC

GUANFACINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL GUANFACINE HYDROCHLORIDE

AB

AB

AB

AB

ACTAVIS ELIZABETH

INTUNIV

EQ 1MG BASE

EQ 2MG BASE

EQ 3MG BASE

EQ 4MG BASE

A200881

A200881

A200881

A200881

001

002

003

004

Oct 05, 2012

Oct 05, 2012

Oct 05, 2012

Oct 05, 2012

Sep

Sep

Sep

Sep

NEWA

NEWA

NEWA

NEWA

AB

AB

AB

AB +

SHIRE EQ 1MG BASE

EQ 2MG BASE

EQ 3MG BASE

EQ 4MG BASE

N022037

N022037

N022037

N022037

001

002

003

004

Sep 02, 2009

Sep 02, 2009

Sep 02, 2009

Sep 02, 2009

Sep

Sep

Sep

Sep

CFTG

CFTG

CFTG

CFTG

HALOBETASOL PROPIONATE

CREAM; TOPICAL HALOBETASOL PROPIONATE

AB FOUGERA PHARMS 0.05% A077001 001 Dec 16, 2004 Jan CAHN

OINTMENT; TOPICAL HALOBETASOL PROPIONATE

AB FOUGERA PHARMS

@ VENUS PHARMS

0.05%

0.05%

A076903

A077109

001

001

Dec 16, 2004

Jun 14, 2005

Jan

Jun

CAHN

CAHN

HEPARIN SODIUM

AP

AP

AP

AP

INJECTABLE; INJECTION HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ B BRAUN 200 UNITS/100ML 001 Jul 20, 1992 N019953

HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER @ BAXTER HLTHCARE 2,000 UNITS/100ML 002 Jul 09, 1985 N018814

HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER @ BAXTER HLTHCARE 4,000 UNITS/100ML 001 Oct 31, 1983 N018814

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 4,000 UNITS/100ML 001 Jul 20, 1992 N019952

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER @ BAXTER HLTHCARE 5,000 UNITS/100ML 003 Jul 09, 1985 N018814

@ 10,000 UNITS/100ML 004 Jul 02, 1987 N018814

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 5,000 UNITS/100ML 004 Jul 20, 1992 N019952

+ 10,000 UNITS/100ML 005 Jul 20, 1992 N019952

Jul

Mar

Mar

Jul

Mar

Mar

Jul

Jul

CRLD

DISC

DISC

CRLD

DISC

DISC

CRLD

CRLD

HEXAMINOLEVULINATE HYDROCHLORIDE

FOR SOLUTION; INTRAVESICAL CYSVIEW KIT

+ PHOTOCURE ASA 100MG/VIAL N022555 001 May 28, 2010 May CAHN

HYALURONIDASE

INJECTABLE; INJECTION HYDASE @ AKORN INC 150 UNITS/ML N021716 001 Oct 25, 2005 Jun DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 68: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-59

HYDRALAZINE HYDROCHLORIDE

TABLET; ORAL HYDRALAZINE HYDROCHLORIDE

>A> AB ALKEM LABS LTD 10MG A200737 001 Dec 07, 2012 Nov NEWA

>A> AB 25MG A200737 002 Dec 07, 2012 Nov NEWA

>A> AB 50MG A200737 003 Dec 07, 2012 Nov NEWA

>A> AB 100MG A200737 004 Dec 07, 2012 Nov NEWA

HYDROCHLOROTHIAZIDE

CAPSULE; ORAL HYDROCHLOROTHIAZIDE

AB LANNETT HOLDINGS INC 12.5MG A091662 001 Jan 27, 2012 Jan NEWA

TABLET; ORAL HYDROCHLOROTHIAZIDE

AB ACCORD HLTHCARE 12.5MG A202556 001 Sep 24, 2012 Sep NEWA

AB 25MG A202556 002 Sep 24, 2012 Sep NEWA

AB 50MG A202556 003 Sep 24, 2012 Sep NEWA

HYDROCHLOROTHIAZIDE; IRBESARTAN

TABLET; ORAL AVALIDE

AB

AB

+ SANOFI AVENTIS 12.5MG;150MG

+ 12.5MG;300MG

N020758

N020758

002

003

Sep 30, 1997

Aug 31, 1998

Mar

Mar

CFTG

CFTG

+ 12.5MG;300MG N020758 003 Aug 31, 1998 Feb CRLD

IRBESARTAN AND HYDROCHLOROTHIAZIDE AB ALEMBIC LTD 12.5MG;150MG A091370 001 Oct 15, 2012 Oct NEWA

AB 12.5MG;300MG A091370 002 Oct 15, 2012 Oct NEWA

AB APOTEX INC 12.5MG;150MG A201505 001 Oct 15, 2012 Oct NEWA

AB 12.5MG;300MG A201505 002 Oct 15, 2012 Oct NEWA

AB DR REDDYS LABS LTD 12.5MG;150MG A203500 001 Sep 27, 2012 Sep NEWA

AB 12.5MG;300MG A203500 002 Sep 27, 2012 Sep NEWA

AB

AB

AB

AB

MACLEODS PHARMS LTD 12.5MG;150MG

12.5MG;300MG

MYLAN PHARMS INC 12.5MG;150MG

12.5MG;300MG

A202414

A202414

A077969

A077969

001

002

001

002

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep

Sep

Sep

Sep

NEWA

NEWA

NEWA

NEWA

AB ROXANE 12.5MG;150MG A090351 001 Oct 15, 2012 Oct NEWA

AB 12.5MG;300MG A090351 002 Oct 15, 2012 Oct NEWA

AB SANDOZ 12.5MG;150MG A077446 001 Sep 27, 2012 Sep NEWA

AB

AB

12.5MG;300MG

TEVA 12.5MG;150MG

A077446

A077369

002

001

Sep 27, 2012

Mar 30, 2012

Sep

Mar

NEWA

NEWA

AB 12.5MG;300MG A077369 002 Mar 30, 2012 Mar NEWA

@ 25MG;300MG A077369 003 Mar 30, 2012 Apr DISC

25MG;300MG A077369 003 Mar 30, 2012 Mar NEWA

AB WATSON LABS INC 12.5MG;150MG A091539 001 Oct 22, 2012 Oct NEWA

AB 12.5MG;300MG A091539 002 Oct 22, 2012 Oct NEWA

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET; ORAL LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AB ALEMBIC LTD 12.5MG;50MG A091617 001 Feb 17, 2012 Feb NEWA

AB 12.5MG;100MG A091617 002 Feb 17, 2012 Feb NEWA

AB 25MG;100MG A091617 003 Feb 17, 2012 Feb NEWA

AB ALEMBIC PHARMS LTD 12.5MG;50MG A091617 001 Feb 17, 2012 Sep CAHN

AB 12.5MG;100MG A091617 002 Feb 17, 2012 Sep CAHN

AB 25MG;100MG A091617 003 Feb 17, 2012 Sep CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 69: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-60

TABLET; ORAL LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AB

AB

AB

AB

AB

AB

CADISTA PHARMS

MACLEODS PHARMS LTD

12.5MG;50MG

12.5MG;100MG

25MG;100MG

12.5MG;50MG

12.5MG;100MG

25MG;100MG

A201845

A201845

A201845

A202289

A202289

A202289

001

002

003

001

002

003

Sep 18, 2012

Sep 18, 2012

Sep 18, 2012

Aug 09, 2012

Aug 09, 2012

Aug 09, 2012

Sep

Sep

Sep

Jul

Jul

Jul

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE; ORAL DUTOPROL

+

ASTRAZENECA 12.5MG;EQ 25MG TARTRATE

12.5MG;EQ 50MG TARTRATE

12.5MG;EQ 100MG TARTRATE

12.5MG;EQ 100MG TARTRATE

N021956

N021956

N021956

N021956

001

002

003

003

Aug 28, 2006

Aug 28, 2006

Aug 28, 2006

Aug 28, 2006

Jan

Jan

Apr

Jan

CMFD

CMFD

CRLD

CMFD

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET; ORAL LOPRESSOR HCT

AB

AB +

US PHARMS HOLDINGS I 25MG;50MG

25MG;100MG

@ 50MG;100MG

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

N018303

N018303

N018303

001

002

003

Dec 31, 1984

Dec 31, 1984

Dec 31, 1984

Sep

Sep

Sep

CAHN

CAHN

CAHN

AB

AB

AB

AB

MYLAN

SUN PHARM INDS

50MG;100MG

25MG;50MG

25MG;100MG

50MG;100MG

A076792

A090654

A090654

A090654

003

001

002

003

Aug 20, 2004

Jan 19, 2012

Jan 19, 2012

Jan 19, 2012

Jan

Jan

Jan

Jan

CTEC

NEWA

NEWA

NEWA

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET; ORAL MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE @ PADDOCK LLC

@

@

12.5MG;7.5MG

12.5MG;15MG

25MG;15MG

A090096

A090096

A090096

001

002

003

Sep 25, 2008

Sep 25, 2008

Sep 25, 2008

Jan

Jan

Jan

DISC

DISC

DISC

HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET; ORAL DIOVAN HCT

AB

AB

AB

AB

AB +

NOVARTIS 12.5MG;80MG

12.5MG;160MG

12.5MG;320MG

25MG;160MG

25MG;320MG

VALSARTAN AND HYDROCHLOROTHIAZIDE

N020818

N020818

N020818

N020818

N020818

001

002

004

003

005

Mar 06, 1998

Mar 06, 1998

Apr 28, 2006

Jan 17, 2002

Apr 28, 2006

Sep

Sep

Sep

Sep

Sep

CFTG

CFTG

CFTG

CFTG

CFTG

AB

AB

AB

AB

AB

MYLAN PHARMS INC 12.5MG;80MG

12.5MG;160MG

12.5MG;320MG

25MG;160MG

25MG;320MG

A078020

A078020

A078020

A078020

A078020

001

002

004

003

005

Sep 21, 2012

Sep 21, 2012

Sep 21, 2012

Sep 21, 2012

Sep 21, 2012

Sep

Sep

Sep

Sep

Sep

NEWA

NEWA

NEWA

NEWA

NEWA

HYDROCORTISONE

CREAM; TOPICAL HYTONE @ VALEANT INTL

@

1%

2.5%

A080472

A080472

003

004

Sep

Sep

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 70: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-61

CREAM; TOPICAL NUTRACORT @ DOW PHARM 0.5% A080442 002 Jun CAHN

@ 1% A080442 003 Jun CAHN

LOTION; TOPICAL CETACORT @ DOW PHARM 0.5% A080426 002 Jun CAHN

@ 1% A080426 001 Jun CAHN

HYDROCORTISONE AT + FOUGERA PHARMS 2.5% A040351 001 Jul 25, 2000 Jan CAHN

HYTONE @ VALEANT INTL

@

1%

2.5%

A080473

A080473

003

004 Nov 30, 1982

Sep

Sep

CAHN

CAHN

NUTRACORT @ DOW PHARM 0.5% A080443 002 Jun CAHN

AT 1% A080443 003 Jun CAHN

AT 2.5% A087644 001 Aug 24, 1982 Jun CAHN

OINTMENT; TOPICAL HYDROCORTISONE

AT + FOUGERA PHARMS 1% A080692 001 Jan CAHN

TABLET; ORAL HYDROCORTISONE

>A> AB AMEDRA PHARMS 5MG A040646 001 Mar 30, 2007 Nov CAHN

>A> AB 10MG A040646 002 Mar 30, 2007 Nov CAHN

>A> AB 20MG A040646 003 Mar 30, 2007 Nov CAHN

>D> AB COREPHARMA 5MG A040646 001 Mar 30, 2007 Nov CAHN

>D> AB 10MG A040646 002 Mar 30, 2007 Nov CAHN

>D> AB 20MG A040646 003 Mar 30, 2007 Nov CAHN

HYDROCORTISONE ACETATE; UREA

CREAM; TOPICAL CARMOL HC

AT FOUGERA PHARMS 1%;10% A080505 001 Jan CAHN

HYDROCORTISONE BUTYRATE

CREAM; TOPICAL LOCOID

AB + PRECISION DERMAT 0.1% N018514 001 Mar 31, 1982 Jun CAHN

LOCOID LIPOCREAM + PRECISION DERMAT 0.1% N020769 001 Sep 08, 1997 Jun CAHN

LOTION; TOPICAL LOCOID

+ PRECISION DERMAT 0.1% N022076 001 May 18, 2007 May CAHN

OINTMENT; TOPICAL LOCOID

AB + PRECISION DERMAT 0.1% N018652 001 Oct 29, 1982 May CAHN

SOLUTION; TOPICAL LOCOID

AT + PRECISION DERMAT 0.1% N019116 001 Feb 25, 1987 Jun CAHN

HYDROCORTISONE VALERATE

CREAM; TOPICAL HYDROCORTISONE VALERATE

AB + TARO 0.2% A075042 001 Aug 25, 1998 Mar CRLD

WESTCORT @ RANBAXY 0.2% N017950 001 Mar DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 71: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-62

AB

OINTMENT; TOPICAL HYDROCORTISONE VALERATE

FOUGERA PHARMS 0.2% A075085 001 Jul 31, 2001 Jan CAHN

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

AT

SOLUTION/DROPS; OTICNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

ALCON PHARMS LTD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

A062423 001 Aug 25, 1983 Sep CAHN

HYDROFLUMETHIAZIDE

AB

TABLET; ORAL SALURON

+ SHIRE LLC 50MG N011949 001 Jan CAHN

HYDROMORPHONE HYDROCHLORIDE

TABLET; ORAL HYDROMORPHONE HYDROCHLORIDE @ NESHER PHARMS 2MG

@ 4MG

@ 8MG

TABLET, EXTENDED RELEASE; ORAL EXALGO

MALLINCKRODT INC 32MG

A077311

A077311

A077311

N021217

001

002

003

004

Nov 09, 2005

Nov 09, 2005

Nov 09, 2005

Aug 24, 2012

Jun

Jun

Jun

Aug

DISC

DISC

DISC

NEWA

HYDROXYCHLOROQUINE SULFATE

TABLET; ORAL HYDROXYCHLOROQUINE SULFATE @ SANDOZ 200MG A040150 001 Jan 27, 1996 Oct DISC

HYDROXYZINE HYDROCHLORIDE

SYRUP; ORAL HYDROXYZINE HYDROCHLORIDE @ STI PHARMA LLC 10MG/5ML

TABLET; ORAL HYDROXYZINE HYDROCHLORIDE @ MIKAH PHARMA 10MG

@ 25MG

@ 50MG

A086880

A040600

A040602

A040604

001

001

001

001

Dec 28, 2004

Dec 28, 2004

Dec 28, 2004

Feb

Jul

Jul

Jul

CAHN

CAHN

CAHN

CAHN

HYDROXYZINE PAMOATE

SUSPENSION; ORAL VISTARIL @ PFIZER EQ 25MG HCL/5ML N011795 001 Jul DISC

IBANDRONATE SODIUM

AB

TABLET; ORAL BONIVA

+ HOFFMANN LA ROCHE

IBANDRONATE SODIUM

EQ 150MG BASE N021455 002 Mar 24, 2005 Mar CFTG

AB

AB

AB

AB

AB

AB

APOTEX INC

DR REDDYS LABS LTD

MUTUAL PHARM CO INC

MYLAN PHARMS INC

ORCHID HLTHCARE

WATSON LABS INC

EQ 150MG BASE

EQ 150MG BASE

EQ 150MG BASE

EQ 150MG BASE

EQ 150MG BASE

EQ 150MG BASE

A078948

A078997

A078996

A078995

A078998

A079003

001

001

001

001

001

001

Mar 19, 2012

Apr 30, 2012

Aug 15, 2012

Mar 19, 2012

Mar 19, 2012

Mar 20, 2012

Mar

Apr

Jul

Mar

Mar

Mar

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 72: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-63

IBUPROFEN

TABLET; ORAL IBUPROFEN @ NORTHSTAR HLTHCARE

@

@

@ OHM LABS

400MG

600MG

800MG

400MG

A078132

A078132

A078132

A070818

001

002

003

001

Sep 10, 2007

Sep 10, 2007

Sep 10, 2007

Dec 26, 1985

Jun

Jun

Jun

Jun

DISC

DISC

DISC

DISC

IBUPROFEN LYSINE

INJECTABLE; INTRAVENOUS NEOPROFEN

+ LUNDBECK LLC EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

N021903 001 Apr 13, 2006 Mar CAHN

ICOSAPENT ETHYL

CAPSULE; ORAL VASCEPA

+ AMARIN PHARMA INC 1GM N202057 001 Jul 26, 2012 Jul NEWA

IDARUBICIN HYDROCHLORIDE

INJECTABLE; INJECTION IDARUBICIN HYDROCHLORIDE

AP ONCO THERAPIES LTD

@ TEVA PARENTERAL

@

@

1MG/ML

5MG/VIAL

10MG/VIAL

20MG/VIAL

A200144

A065037

A065037

A065037

001

003

002

001

Oct 11, 2012

May 01, 2002

May 01, 2002

May 01, 2002

Sep

Mar

Mar

Mar

NEWA

DISC

DISC

DISC

IFOSFAMIDE

INJECTABLE; INJECTION IFOSFAMIDE

>A>

>A>

AP

AP

ONCO THERAPIES LTD 1GM/20ML (50MG/ML)

3GM/60ML (50MG/ML)

A201689

A201689

001

002

Nov 26, 2012

Nov 26, 2012

Nov

Nov

NEWA

NEWA

IMIPRAMINE HYDROCHLORIDE

TABLET; ORAL IMIPRAMINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

EXCELLIUM

PROSAM LABS

10MG

25MG

50MG

10MG

25MG

50MG

A040903

A040903

A040903

A040753

A040752

A040751

001

002

003

001

001

001

Oct 24, 2012

Oct 24, 2012

Oct 24, 2012

Feb 28, 2008

Feb 28, 2008

Feb 28, 2008

Oct

Oct

Oct

Feb

Feb

Feb

NEWA

NEWA

NEWA

CMFD

CMFD

CMFD

IMIQUIMOD

AB

AB

AB

CREAM; TOPICAL IMIQUIMOD

APOTEX INC

FOUGERA PHARMS

GLENMARK GENERICS

5%

5%

5%

A091308

A078548

A201994

001

001

001

Apr 06, 2012

Feb 25, 2010

Mar 06, 2012

Mar

Jan

Feb

NEWA

CAHN

NEWA

INDAPAMIDE

TABLET; ORAL INDAPAMIDE

AB

AB

MYLAN PHARMS INC 1.25MG

2.5MG

A075105

A075105

001

002

Jul 23, 1998

Jul 23, 1998

Sep

Sep

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 73: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-64

TABLET; ORAL INDAPAMIDE @ SANDOZ 1.25MG A074594 001

@ 2.5MG A074594 002

INDOMETHACIN

CAPSULE, EXTENDED RELEASE; ORAL INDOMETHACIN

AB HETERO LABS LTD III 75MG A201807 001

INDOMETHACIN SODIUM

INJECTABLE; INJECTION INDOCIN

AP + LUNDBECK LLC EQ 1MG BASE/VIAL N018878 001

INGENOL MEBUTATE

GEL; TOPICAL PICATO

LEO PHARMA AS 0.015% N202833 001

+ 0.05% N202833 002

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS NOVOLOG MIX 70/30

>D> + NOVO NORDISK INC 70 UNITS/ML;30 UNITS/ML N021172 001

>A> + 700 UNITS/10ML; 300 UNITS/10ML N021172 001 (70 UNITS/ML; 30 UNITS/ML)

>A> NOVOLOG MIX 70/30 FLEXPEN>A> + NOVO NORDISK INC 210 UNITS/3ML; 90 UNITS/3ML (70 N021172 004

UNITS/ML; 30 UNITS/ML) >A> NOVOLOG MIX 70/30 PENFILL>A> @ NOVO NORDISK INC 210 UNITS/3ML; 90 UNITS/3ML (70 N021172 003

UNITS/ML; 30 UNITS/ML) >A> @ 210 UNITS/3ML; 90 UNITS/3ML (70 N021172 002

UNITS/ML; 30 UNITS/ML)

INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS NOVOLOG

>D> + NOVO NORDISK INC 100 UNITS/ML N020986 001

>A> + 1000 UNITS/10ML (100 UNITS/ML) N020986 001

>A> NOVOLOG FLEXPEN >A> + NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 003

>A> NOVOLOG INNOLET >A> @ NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 004

>A> NOVOLOG PENFILL >A> + NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 002

INSULIN DETEMIR RECOMBINANT

INJECTABLE; SUBCUTANEOUS LEVEMIR

>D> + NOVO NORDISK INC 100 UNITS/ML N021536 001

>A> + 1000 UNITS/10ML (100 UNITS/ML) N021536 001

>A> LEVEMIR FLEXPEN >A> + NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 002

>A> LEVEMIR INNOLET >A> @ NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 003

May 23, 1996

May 23, 1996

Sep 28, 2012

Jan 30, 1985

Jan 23, 2012

Jan 23, 2012

Nov 01, 2001

Nov 01, 2001

May 03, 2002

Nov 01, 2001

Nov 01, 2001

Jun 07, 2000

Jun 07, 2000

Jan 19, 2001

Apr 23, 2004

Jun 07, 2000

Jun 16, 2005

Jun 16, 2005

Jun 16, 2005

Jun 16, 2005

Oct

Oct

Sep NEWA

Mar CAHN

Jan NEWA

Jan NEWA

Nov CPOT

Nov CPOT

Nov NEWA

Nov NEWA

Nov NEWA

Nov CPOT

Nov CPOT

Nov NEWA

Nov NEWA

Nov NEWA

Nov CPOT

Nov CPOT

Nov NEWA

Nov NEWA

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 74: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-65

>A> INJECTABLE; SUBCUTANEOUS

LEVEMIR PENFILL >A> @ NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 004 Jun 16, 2005 Nov NEWA

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

INJECTABLE; INJECTION HUMALOG MIX 50/50 PEN@ LILLY

HUMALOG MIX 75/25 PEN@ LILLY

50 UNITS/ML;50 UNITS/ML

75 UNITS/ML;25 UNITS/ML

N021018

N021017

003

003

Dec 22, 1999

Dec 22, 1999

Jun

Jun

DISC

DISC

INSULIN LISPRO RECOMBINANT

INJECTABLE; INJECTION HUMALOG PEN @ LILLY 100 UNITS/ML N020563 002 Aug 06, 1998 Jun DISC

IOTHALAMATE SODIUM I-125

INJECTABLE; INJECTION GLOFIL-125

ISOTEX 250-300uCi/ML N017279 001 Oct CMFD

IPRATROPIUM BROMIDE

SOLUTION; INHALATION IPRATROPIUM BROMIDE

AN TEVA PHARMS 0.02% A075313 001 Feb 07, 2000 Sep CAHN

IRBESARTAN

TABLET; ORAL AVAPRO

AB

AB

AB +

SANOFI AVENTIS US

IRBESARTAN

75MG

150MG

300MG

N020757

N020757

N020757

001

002

003

Sep 30, 1997

Sep 30, 1997

Sep 30, 1997

Mar

Mar

Mar

CFTG

CFTG

CFTG

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

ALEMBIC PHARMS LTD

APOTEX INC

AUROBINDO PHARMA LTD

CIPLA LTD

DR REDDYS LABS LTD

HETERO LABS LTD V

LUPIN LTD

MACLEODS PHARMS LTD

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

A091236

A091236

A091236

A200832

A200832

A200832

A203081

A203081

A203081

A077205

A077205

A077205

A203161

A203161

A203161

A202910

A202910

A202910

A201531

A201531

A201531

A202254

A202254

001

002

003

001

002

003

001

002

003

001

002

003

001

002

003

001

002

003

001

002

003

001

002

Oct 15, 2012

Oct 15, 2012

Oct 15, 2012

Oct 15, 2012

Oct 15, 2012

Oct 15, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Nov 14, 2012

Nov 14, 2012

Nov 14, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Oct 15, 2012

Oct 15, 2012

Oct 15, 2012

Oct 03, 2012

Oct 03, 2012

Oct

Oct

Oct

Oct

Oct

Oct

Sep

Sep

Sep

Oct

Oct

Oct

Sep

Sep

Sep

Sep

Sep

Sep

Oct

Oct

Oct

Sep

Sep

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 75: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-66

TABLET; ORAL IRBESARTAN

AB

AB

AB

AB

MACLEODS PHARMS LTD

MYLAN PHARMS INC

300MG

75MG

150MG

300MG

A202254

A200461

A200461

A200461

003

001

002

003

Oct 03, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep

Sep

Sep

Sep

NEWA

NEWA

NEWA

NEWA

AB PRINSTON INC 75MG A203071 001 Sep 27, 2012 Sep NEWA

AB 150MG A203071 002 Sep 27, 2012 Sep NEWA

AB

AB ROXANE

300MG

75MG

A203071

A090201

003

001

Sep 27, 2012

Oct 15, 2012

Sep

Oct

NEWA

NEWA

AB 150MG A090201 002 Oct 15, 2012 Oct NEWA

AB 300MG A090201 003 Oct 15, 2012 Oct NEWA

AB SANDOZ 75MG A077466 001 Sep 27, 2012 Sep NEWA

AB 150MG A077466 002 Sep 27, 2012 Sep NEWA

AB 300MG A077466 003 Sep 27, 2012 Sep NEWA

AB TEVA PHARMS 75MG A077159 001 Mar 30, 2012 Mar NEWA

AB 150MG A077159 002 Mar 30, 2012 Mar NEWA

AB 300MG A077159 003 Mar 30, 2012 Mar NEWA

AB

AB

WATSON LABS INC 75MG

150MG

A090720

A090720

001

002

Oct 12, 2012

Oct 12, 2012

Sep

Sep

NEWA

NEWA

AB 300MG A090720 003 Oct 12, 2012 Sep NEWA

AB ZYDUS PHARMS USA INC 75MG A079213 001 Sep 27, 2012 Sep NEWA

AB

AB

150MG

300MG

A079213

A079213

002

003

Sep 27, 2012

Sep 27, 2012

Sep

Sep

NEWA

NEWA

IRINOTECAN HYDROCHLORIDE

INJECTABLE; INJECTION IRINOTECAN HYDROCHLORIDE

AP CIPLA LTD 40MG/2ML (20MG/ML) A077219 001 Feb 20, 2008 Mar CAHN

AP

AP

AP

AP

AP

EMCURE PHARMS LTD

HISUN PHARM HANGZHOU

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

A077219

A200771

A200771

A090016

A090016

002

001

002

001

002

Feb 20, 2008

Feb 14, 2012

Feb 14, 2012

Jan 28, 2009

Jan 28, 2009

Mar

Jan

Jan

Mar

Mar

CAHN

NEWA

NEWA

CAHN

CAHN

AP TEVA PARENTERAL 40MG/2ML (20MG/ML) A090101 002 Feb 27, 2008 Jun NEWA

AP 100MG/5ML (20MG/ML) A090101 003 Feb 27, 2008 Jun NEWA

AP

@

500MG/25ML (20MG/ML)

500MG/25ML (20MG/ML)

A090101

A090101

001

001

Nov 26, 2008

Nov 26, 2008

Jun

Mar

CMFD

DISC

ISOFLURANE

LIQUID; INHALATION FORANE

AN + BAXTER HLTHCARE 99.9% N017624 001 Jul CAHN

ISOSORBIDE MONONITRATE

TABLET; ORAL MONOKET

AB KREMERS URBAN PHARMS 10MG N020215 002 Jun 30, 1993 Oct CAHN

AB + 20MG N020215 001 Jun 30, 1993 Oct CAHN

TABLET, EXTENDED RELEASE; ORAL ISOSORBIDE MONONITRATE

AB ALKERMES GAINESVILLE 60MG A075041 001 Sep 22, 1998 Jun CAHN

@ SKYEPHARMA AG 60MG A075166 001 Oct 07, 1999 Jan DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 76: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-67

ISOSULFAN BLUE

INJECTABLE; INJECTION ISOSULFAN BLUE

AP MYLAN INSTITUTIONAL 1% A090874 001 Jul 20, 2010 Oct CAHN

ISOTRETINOIN

CAPSULE; ORAL ABSORICA

BX

BX

BX

BX

CIPHER

MYORISAN

10MG

10MG

20MG

20MG

30MG

30MG

40MG

40MG

N021951

N021951

N021951

N021951

N021951

N021951

N021951

N021951

001

001

002

002

003

003

004

004

May 25, 2012

May 25, 2012

May 25, 2012

May 25, 2012

May 25, 2012

May 25, 2012

May 25, 2012

May 25, 2012

Sep

May

Sep

May

Sep

May

Sep

May

CTEC

NEWA

CTEC

NEWA

CTEC

NEWA

CTEC

NEWA

AB

AB

AB

DOUGLAS PHARMS 10MG

20MG

40MG

A076485

A076485

A076485

001

002

003

Jan 19, 2012

Jan 19, 2012

Jan 19, 2012

Jan

Jan

Jan

NEWA

NEWA

NEWA

ITRACONAZOLE

CAPSULE; ORAL ITRACONAZOLE

AB MYLAN PHARMS INC 100MG A200463 001 Jul 20, 2012 Jul NEWA

IVACAFTOR

TABLET; ORAL KALYDECO

+ VERTEX PHARMS 150MG N203188 001 Jan 31, 2012 Jan NEWA

IVERMECTIN

LOTION; TOPICAL SKLICE

+ SANOFI PASTEUR

TABLET; ORAL STROMECTOL

0.5% N202736 001 Feb 07, 2012 Feb NEWA

>D>

>D>

>A>

>A>

+

+

@

@

MERCK

MERCK SHARP DOHME

3MG

6MG

3MG

6MG

N050742

N050742

N050742

N050742

002

001

002

001

Oct 08, 1998

Nov 22, 1996

Oct 08, 1998

Nov 22, 1996

Nov

Nov

Nov

Nov

CAHN

CAHN

CAHN

CAHN

KANAMYCIN SULFATE

INJECTABLE; INJECTION KANAMYCIN @ HIKMA MAPLE

@

@

EQ 75MG BASE/2ML

EQ 500MG BASE/2ML

EQ 1GM BASE/3ML

A062324

A062324

A062324

001

002

003

Sep

Sep

Sep

CAHN

CAHN

CAHN

KETOCONAZOLE

CREAM; TOPICAL KETOCONAZOLE

AB FOUGERA PHARMS 2% A076294 001 Apr 28, 2004 Jan CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 77: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-68

KETOPROFEN

CAPSULE; ORAL KETOPROFEN

AB

AB

DORADO PHARMA 25MG

50MG

75MG

CAPSULE, EXTENDED RELEASE; ORAL KETOPROFEN

A074014

A074014

A074014

001

002

003

Jan 29, 1993

Jan 29, 1993

Jan 29, 1993

Jul

Jul

Jul

CAHN

CAHN

CAHN

AB

@ ALKERMES GAINESVILLE 200MG

200MG

A074879

A074879

001

001

Dec 10, 1997

Dec 10, 1997

Oct

Jun

DISC

CAHN

KETOROLAC TROMETHAMINE

INJECTABLE; INJECTION KETOROLAC TROMETHAMINE

AP

AP

AP

AP

HIKMA MAPLE 15MG/ML

15MG/ML

30MG/ML

30MG/ML

A075772

A075299

A075772

A075299

001

001

002

002

Jul 21, 2004

Nov 03, 1999

Jul 21, 2004

Nov 03, 1999

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

LABETALOL HYDROCHLORIDE

INJECTABLE; INJECTION LABETALOL HYDROCHLORIDE

AP GLAND PHARMA LTD

TABLET; ORAL LABETALOL HYDROCHLORIDE

5MG/ML A090699 001 Apr 03, 2012 Mar NEWA

AB

AB

AB

PAR FORM 100MG

200MG

300MG

A200908

A200908

A200908

001

002

003

Jul 10, 2012

Jul 10, 2012

Jul 10, 2012

Jun

Jun

Jun

NEWA

NEWA

NEWA

LACTULOSE

FOR SOLUTION; ORAL LACTULOSE

+ CUMBERLAND PHARMS

+

SOLUTION; ORAL LACTULOSE

10GM/PACKET

20GM/PACKET

A074712

A074712

001

002

Dec 10, 1997

Dec 10, 1997

Jun

Jun

CAHN

CAHN

AA FRESENIUS KABI

SOLUTION; ORAL, RECTAL LACTULOSE

10GM/15ML A090503 001 Jan 25, 2012 Jan NEWA

AA FRESENIUS KABI 10GM/15ML A090502 001 Jan 25, 2012 Jan NEWA

LAMIVUDINE; ZIDOVUDINE

TABLET; ORAL LAMIVUDINE AND ZIDOVUDINE

AB

AB

AUROBINDO PHARMA LTD

LUPIN LTD

150MG;300MG

150MG;300MG

A202418

A090246

001

001

May 15, 2012

May 15, 2012

Apr

Apr

NEWA

NEWA

LAMOTRIGINE

TABLET; ORAL LAMOTRIGINE

AB

AB

AB

AB

BX

GLENMARK GENERICS

UPSHER SMITH

25MG

100MG

150MG

200MG

25MG

A090169

A090169

A090169

A090169

A078310

001

002

003

004

001

May 12, 2012

May 12, 2012

May 12, 2012

May 12, 2012

Feb 04, 2009

Apr

Apr

Apr

Apr

Aug

NEWA

NEWA

NEWA

NEWA

CTEC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 78: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-69

TABLET; ORAL LAMOTRIGINE

BX

BX

BX

UPSHER SMITH 100MG

150MG

200MG

A078310

A078310

A078310

002

003

004

Feb 04, 2009

Feb 04, 2009

Feb 04, 2009

Aug

Aug

Aug

CTEC

CTEC

CTEC

LANREOTIDE ACETATE

INJECTABLE; SUBCUTANEOUS SOMATULINE DEPOT

+

+

+

+

+

+

IPSEN INC

IPSEN PHARMA

EQ 60MG BASE

EQ 90MG BASE

EQ 120MG BASE

EQ 60MG BASE

EQ 90MG BASE

EQ 120MG BASE

N022074

N022074

N022074

N022074

N022074

N022074

001

002

003

001

002

003

Aug 30, 2007

Aug 30, 2007

Aug 30, 2007

Aug 30, 2007

Aug 30, 2007

Aug 30, 2007

Apr

Apr

Apr

May

May

May

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS; ORAL LANSOPRAZOLE

AB

AB

AB

AB

MYLAN PHARMS INC

WOCKHARDT USA

PREVACID

15MG

30MG

15MG

30MG

A090763

A090763

A202176

A202176

001

002

001

002

Nov 10, 2009

Nov 10, 2009

Sep 14, 2012

Sep 14, 2012

Sep

Sep

Aug

Aug

CAHN

CAHN

NEWA

NEWA

AB

AB

TAKEDA PHARMS USA 15MG

+ 30MG

TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING; ORAL LANSOPRAZOLE

N020406

N020406

001

002

May 10, 1995

May 10, 1995

Mar

Mar

CAHN

CAHN

@ TEVA PHARMS

@

PREVACID

15MG

30MG

A078730

A078730

001

002

Oct 15, 2010

Oct 15, 2010

Mar

Mar

DISC

DISC

+

TAKEDA PHARMS USA 15MG

30MG

N021428

N021428

001

002

Aug 30, 2002

Aug 30, 2002

Mar

Mar

CTEC

CTEC

LANTHANUM CARBONATE

TABLET, CHEWABLE; ORAL FOSRENOL

+

@ SHIRE LLC EQ 250MG BASE

EQ 500MG BASE

EQ 750MG BASE

EQ 1GM BASE

N021468

N021468

N021468

N021468

001

002

003

004

Oct 26, 2004

Oct 26, 2004

Nov 23, 2005

Nov 23, 2005

Feb

Feb

Feb

Feb

CAHN

CAHN

CAHN

CAHN

LATANOPROST

SOLUTION/DROPS; OPHTHALMICLATANOPROST

AT AKORN 0.005% A090887 001 Jul 19, 2011 Sep CAHN

LENALIDOMIDE

CAPSULE; ORAL REVLIMID

CELGENE 15MG N021880 003 Jun 29, 2006 Sep CRLD

LETROZOLE

TABLET; ORAL LETROZOLE

AB APOTEX INC 2.5MG A091303 001 Apr 19, 2012 Apr NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 79: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-70

TABLET; ORAL LETROZOLE

AB VINTAGE PHARMS LLC 2.5MG A090789 001 Jun 03, 2011 Sep CAHN

LEUCOVORIN CALCIUM

INJECTABLE; INJECTION LEUCOVORIN CALCIUM @ TEVA PARENTERAL EQ 50MG BASE/VIAL

LEUCOVORIN CALCIUM PRESERVATIVE FREE

A081278 001 Sep 28, 1993 Mar DISC

AP

AP

AP

AP

SAGENT PHARMS EQ 50MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 200MG BASE/VIAL

EQ 350MG BASE/VIAL

A200753

A200753

A200753

A200855

001

002

003

001

Sep 06, 2012

Sep 06, 2012

Sep 06, 2012

Sep 06, 2012

Aug

Aug

Aug

Aug

NEWA

NEWA

NEWA

NEWA

LEUPROLIDE ACETATE

INJECTABLE; INJECTION LUPRON DEPOT

+

+

+

ABBOTT ENDOCRINE 3.75MG/VIAL

7.5MG/VIAL

11.25MG/VIAL

N020011

N019732

N020708

001

001

001

Oct 22, 1990

Jan 26, 1989

Mar 07, 1997

May

May

May

CAHN

CAHN

CAHN

LEVETIRACETAM

INJECTABLE; IV (INFUSION)LEVETIRACETAM

AP

AP

AP

AP

AP

APP PHARMS LLC

HOSPIRA INC

LUITPOLD

PHARMAFORCE

X GEN PHARMS

SOLUTION; ORAL LEVETIRACETAM

500MG/5ML (100MG/ML)

500MG/ML (100MG/ML)

500MG/5ML (100MG/ML)

500MG/5ML (100MG/ML)

500MG/5ML (100MG/ML)

A090813

A202869

A202143

A202143

A091485

001

001

001

001

001

May 26, 2010

Apr 06, 2012

Jan 31, 2012

Jan 31, 2012

Aug 05, 2011

May

Mar

Aug

Jan

Jul

CAHN

NEWA

CAHN

NEWA

CAHN

AA

AA

HI-TECH PHARMACAL

VINTAGE PHARMS

TABLET; ORAL LEVETIRACETAM

100MG/ML

100MG/ML

A090601

A090079

001

001

Feb 28, 2012

Apr 11, 2012

Feb

Mar

NEWA

NEWA

AB

AB

AB

AB

LOTUS PHARM CO LTD 500MG

WATSON LABS INC 250MG

500MG

750MG

TABLET, EXTENDED RELEASE; ORAL LEVETIRACETAM

A090906

A078797

A078797

A078797

001

002

003

004

Nov 05, 2010

Jan 15, 2009

Jan 15, 2009

Jan 15, 2009

Jul

Apr

Apr

Apr

CAHN

NEWA

NEWA

NEWA

AB

AB

AB

AB

AB

AB

AB

AB

BOCA PHARMA

ROUSES POINT PHARMS

SANDOZ

TORRENT PHARMS LTD

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

A201464

A201464

A202524

A202524

A091668

A091668

A091338

A091338

001

002

001

002

001

002

001

002

May 25, 2012

May 25, 2012

Aug 27, 2012

Aug 27, 2012

Nov 01, 2012

Nov 01, 2012

May 29, 2012

May 29, 2012

May

May

Aug

Aug

Oct

Oct

May

May

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET; ORAL LEVOCETIRIZINE DIHYDROCHLORIDE

AB HETERO LABS LTD III 5MG A091264 001 Jun 29, 2012 Jun NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 80: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-71

LEVOFLOXACIN

TABLET; ORAL LEVOFLOXACIN

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

CIPLA LTD

MACLEODS PHARMS LTD

ORCHID HLTHCARE

ZYDUS PHARMS USA INC

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

A076890

A076890

A076890

A200839

A200839

A200839

A202200

A202200

A202200

A077652

A077652

A077652

001

002

003

001

002

003

001

002

003

001

002

003

Mar 30, 2012

Mar 30, 2012

Mar 30, 2012

Mar 22, 2012

Mar 22, 2012

Mar 22, 2012

Jan 30, 2012

Jan 30, 2012

Jan 30, 2012

Sep 07, 2012

Sep 07, 2012

Sep 07, 2012

Mar

Mar

Mar

Mar

Mar

Mar

Jan

Jan

Jan

Aug

Aug

Aug

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

LEVOLEUCOVORIN CALCIUM

SOLUTION; IV (INFUSION)FUSILEV @ SPECTRUM PHARMS EQ 250MG BASE/25ML (EQ 10MG

BASE/ML) N020140 003 Apr 29, 2011 Jun DISC

LEVONORGESTREL

TABLET; ORAL LEVONORGESTREL

AB WATSON LABS INC

PLAN B

1.5MG A200670 001 Jul 12, 2012 Jun NEWA

AB +

@ TEVA BRANDED PHARM

PLAN B ONE-STEP

0.75MG

0.75MG

N021045

N021045

001

002

Jul 28, 1999

Aug 24, 2006

May

May

CAHN

CAHN

AB + DURAMED 1.5MG N021998 001 Jul 10, 2009 Jun CFTG

LIDOCAINE

PATCH; TOPICAL LIDOCAINE

AB WATSON LABS INC

LIDODERM

5% A200675 001 Aug 23, 2012 Aug NEWA

AB + TEIKOKU PHARMA USA 5% N020612 001 Mar 19, 1999 Aug CFTG

LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE

AP

AP

AP

AP

@ HIKMA MAPLE 1%

@ 2%

PFIZER 0.5%

0.5%

1%

1%

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

A080407

A080407

A091056

A091058

A091056

A091058

001

002

001

001

002

002

Dec 08, 2010

Sep 30, 2010

Dec 08, 2010

Sep 30, 2010

Sep

Sep

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

AP

@ HIKMA MAPLE

@

PFIZER

XYLOCAINE DENTAL

1%

2%

2%

A084625

A084625

A090665

001

002

001 Sep 27, 2010

Sep

Sep

Sep

CAHN

CAHN

CAHN

@ DENTSPLY PHARM 2% N021380 001 May DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 81: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-72

LIDOCAINE; PRILOCAINE

AB

CREAM; TOPICAL LIDOCAINE AND PRILOCAINE

FOUGERA PHARMS 2.5%;2.5% A076453 001 Aug 18, 2003 Jan CAHN

LIDOCAINE; TETRACAINE

CREAM; TOPICAL PLIAGLIS

+ GALDERMA LABS LP 7%;7% N021717 001 Jun 29, 2006 Jun CTNA

LINACLOTIDE

CAPSULE; ORAL LINZESS

FOREST LABS INC

+

145MCG

290MCG

N202811

N202811

001

002

Aug 30, 2012

Aug 30, 2012

Aug

Aug

NEWA

NEWA

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

TABLET; ORAL JENTADUETO

BOEHRINGER INGELHEIM

+

2.5MG;500MG

2.5MG;850MG

2.5MG;1GM

N201281

N201281

N201281

001

002

003

Jan 30, 2012

Jan 30, 2012

Jan 30, 2012

Jan

Jan

Jan

NEWA

NEWA

NEWA

LINEZOLID

AP

AP

INJECTABLE; INJECTION LINEZOLID

TEVA PHARMS

ZYVOX + PHARMACIA AND UPJOHN

200MG/100ML

200MG/100ML

A200222

N021131

001

001

Jun 22, 2012

Apr 18, 2000

Jun

Jun

NEWA

CFTG

LIOTHYRONINE SODIUM

>A>

>A>

>A>

AB

AB

AB

TABLET; ORAL LIOTHYRONINE SODIUM

SIGMAPHARM LABS LLC EQ 0.005MG BASE

EQ 0.025MG BASE

EQ 0.05MG BASE

A200295

A200295

A200295

001

002

003

Nov 29, 2012

Nov 29, 2012

Nov 29, 2012

Nov

Nov

Nov

NEWA

NEWA

NEWA

LITHIUM CARBONATE

AB

AB

TABLET, EXTENDED RELEASE; ORAL LITHIUM CARBONATE

MYLAN PHARMS INC 300MG

450MG

A202288

A202219

001

001

Jun 29, 2012

Aug 08, 2012

Jun

Jul

NEWA

NEWA

LOMUSTINE

CAPSULE; ORAL CEENU

BRISTOL MYERS SQUIBB

@

10MG

10MG

40MG

N017588

N017588

N017588

001

001

002

Jun

May

Jun

CMFD

DISC

CMFD

+

@ 40MG

100MG

N017588

N017588

002

003

May

Jun

DISC

CMFD

@ 100MG N017588 003 May DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 82: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-73

LORAZEPAM

>D>

>D>

>D>

>A>

>A>

>A>

AA

AB

AB

AB

AB

AB

AB

CONCENTRATE; ORAL LORAZEPAM

HI-TECH PHARMA CO

INJECTABLE; INJECTION LORAZEPAM @ BEDFORD

@

@ HIKMA MAPLE

@

@ HOSPIRA

TABLET; ORAL LORAZEPAM

ACTAVIS ELIZABETH

SANDOZ

2MG/ML

2MG/ML

4MG/ML

2MG/ML

4MG/ML

2MG/ML

0.5MG

1MG

2MG

0.5MG

1MG

2MG

A200169

A077076

A077076

A074496

A074496

A074300

A071403

A071404

A071141

A071403

A071404

A071141

001

001

002

001

002

001

001

001

001

001

001

001

Jan 30, 2012

Jul 13, 2005

Jul 13, 2005

Sep 28, 1998

Sep 28, 1998

Apr 12, 1994

Apr 21, 1987

Apr 21, 1987

Apr 21, 1987

Apr 21, 1987

Apr 21, 1987

Apr 21, 1987

Jan

Jun

Jun

Sep

Sep

Jun

Nov

Nov

Nov

Nov

Nov

Nov

NEWA

DISC

DISC

CAHN

CAHN

DISC

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

LORCASERIN HYDROCHLORIDE

TABLET; ORAL BELVIQ

+ ARENA PHARMS INC

+ EISAI INC

10MG

10MG

N022529

N022529

001

001

Jun 27, 2012

Jun 27, 2012

Jun

Jul

NEWA

CAHN

LOSARTAN POTASSIUM

AB

AB

AB

AB

AB

AB

AB

AB

AB

TABLET; ORAL LOSARTAN POTASSIUM

CADISTA PHARMS

MACLEODS PHARMS LTD

MICRO LABS LTD INDIA

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

A201170

A201170

A201170

A202230

A202230

A202230

A091541

A091541

A091541

001

002

003

001

002

003

001

002

003

Sep 18, 2012

Sep 18, 2012

Sep 18, 2012

May 30, 2012

May 30, 2012

May 30, 2012

Sep 24, 2012

Sep 24, 2012

Sep 24, 2012

Sep

Sep

Sep

May

May

May

Sep

Sep

Sep

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

LOTEPREDNOL ETABONATE

GEL; OPHTHALMIC LOTEMAX

+ BAUSCH AND LOMB 0.5% N202872 001 Sep 28, 2012 Sep NEWA

LOXAPINE SUCCINATE

CAPSULE; ORAL LOXAPINE SUCCINATE @ MIKAH PHARMA

@

@

@

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

A076868

A076868

A076868

A076868

001

002

003

004

Aug 04, 2005

Aug 04, 2005

Aug 04, 2005

Aug 04, 2005

Jul

Jul

Jul

Jul

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 83: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-74

LUCINACTANT

SUSPENSION; INTRATRACHEAL SURFAXIN

+ DISCOVERY LABS 8.5ML N021746 001 Mar 06, 2012 Apr NEWA

LURASIDONE HYDROCHLORIDE

TABLET; ORAL LATUDA

+

+

+

SUNOVION PHARMS INC 20MG

20MG

20MG

40MG

40MG

40MG

80MG

120MG

N200603

N200603

N200603

N200603

N200603

N200603

N200603

N200603

003

003

003

001

001

001

002

004

Dec 07, 2011

Dec 07, 2011

Dec 07, 2011

Oct 28, 2010

Oct 28, 2010

Oct 28, 2010

Oct 28, 2010

Apr 26, 2012

Oct

Aug

Apr

Oct

Aug

Apr

Apr

Apr

CRLD

CRLD

NEWA

CRLD

CRLD

CRLD

CRLD

NEWA

LUTROPIN ALFA

INJECTABLE; SUBCUTANEOUS LUVERIS @ EMD SERONO 75 IU/VIAL N021322 001 Oct 08, 2004 Jun DISC

MAFENIDE ACETATE

CREAM; TOPICAL SULFAMYLON

+ MYLAN LLC

FOR SOLUTION; TOPICAL SULFAMYLON

EQ 85MG BASE/GM N016763 001 Jun CAHN

+ MYLAN LLC 5% N019832 003 Jun 05, 1998 Jun CAHN

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

TABLET; ORAL MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE @ SANTARUS 343MG;20MG;750MG

@ 343MG;40MG;750MG

N022456

N022456

001

002

Dec 04, 2009

Dec 04, 2009

Jun

Jun

DISC

DISC

MAGNESIUM SULFATE

INJECTABLE; INJECTION MAGNESIUM SULFATE IN PLASTIC CONTAINER

HOSPIRA 20GM/500ML (40MG/ML)

40GM/1000ML(40MG/ML)

N020309

N020309

004

005

Jan 18, 1995

Jan 18, 1995

Jan

Jan

NEWA

NEWA

MALATHION

LOTION; TOPICAL MALATHION

AT

AT

MYLAN PHARMS INC

SUVEN LIFE

0.5%

0.5%

A078743

A091559

001

001

Mar 06, 2009

May 23, 2012

Feb

May

CAHN

NEWA

MANNITOL

POWDER; INHALATION ARIDOL KIT

+ PHARMAXIS LTD N/A,5MG,10MG,20MG,40MG N022368 001 Oct 05, 2010 May CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 84: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-75

MECASERMIN RECOMBINANT

INJECTABLE; SUBCUTANEOUS INCRELEX

+ IPSEN INC 40MG/4ML (10MG/ML) N021839 001 Aug 30, 2005 May CAHN

MECLIZINE HYDROCHLORIDE

TABLET; ORAL MECLIZINE HYDROCHLORIDE

AA

AA

AA

AA

AA

EPIC PHARMA LLC

MYLAN PHARMS INC

12.5MG

25MG

12.5MG

25MG

50MG

A200294

A200294

A202640

A202640

A202640

001

002

001

002

003

Apr 13, 2012

Apr 13, 2012

Sep 17, 2012

Sep 17, 2012

Sep 17, 2012

Mar

Mar

Sep

Sep

Sep

NEWA

NEWA

NEWA

NEWA

NEWA

MEDROXYPROGESTERONE ACETATE

INJECTABLE; INJECTION MEDROXYPROGESTERONE ACETATE @ TEVA PARENTERAL 150MG/ML A076552 001 Oct 27, 2004 Apr DISC

MELPHALAN HYDROCHLORIDE

INJECTABLE; INJECTION MELPHALAN HYDROCHLORIDE

AP MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090270 001 Jun 09, 2009 Sep CAHN

MEMANTINE HYDROCHLORIDE

TABLET; ORAL MEMANTINE HYDROCHLORIDE

AB

AB

@ ORCHID HLTHCARE

@

NAMENDA

5MG

5MG

10MG

10MG

A090044

A090044

A090044

A090044

001

001

002

002

Mar 12, 2012

Mar 12, 2012

Mar 12, 2012

Mar 12, 2012

Mar

Feb

Mar

Feb

DISC

NEWA

DISC

NEWA

AB

AB

+

+

FOREST LABS 5MG

5MG

10MG

10MG

N021487

N021487

N021487

N021487

001

001

002

002

Oct 16, 2003

Oct 16, 2003

Oct 16, 2003

Oct 16, 2003

Mar

Feb

Mar

Feb

CTEC

CTEC

CTEC

CTEC

MEPERIDINE HYDROCHLORIDE

INJECTABLE; INJECTION MEPERIDINE HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

AP

AP

HIKMA MAPLE 25MG/ML

25MG/ML

50MG/ML

50MG/ML

75MG/ML

75MG/ML

100MG/ML

100MG/ML

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

A080445

A080455

A080445

A080455

A080445

A080455

A080445

A080455

001

007

002

008

003

009

004

010

Sep

Sep

Sep

Sep

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

AP HIKMA MAPLE 10MG/ML A081002 001 Jul 30, 1993 Sep CAHN

MEPIVACAINE HYDROCHLORIDE

INJECTABLE; INJECTION POLOCAINE @ DENTSPLY PHARM 3% A088653 001 Aug 21, 1984 May DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 85: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-76

MEQUINOL; TRETINOIN

SOLUTION; TOPICAL SOLAGE @ AQUA PHARMS 2%;0.01% N020922 001 Dec 10, 1999 Jun DISC

MESALAMINE

SUPPOSITORY; RECTAL CANASA @ APTALIS PHARMA US

ROWASA

500MG

1GM

N021252

N021252

001

002

Jan 05, 2001

Nov 05, 2004

Jul

Jul

CAHN

CAHN

@ MEDA PHARMS 500MG N019919 001 Dec 18, 1990 Jan CAHN

MESNA

INJECTABLE; INTRAVENOUS MESNA

AP

AP

MYLAN INSTITUTIONAL

SAGENT AGILA

100MG/ML

100MG/ML

A076488

A090913

001

001

Mar 08, 2012

Apr 13, 2010

Feb

Oct

NEWA

CAHN

METFORMIN HYDROCHLORIDE

TABLET; ORAL METFORMIN HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

MARKSANS PHARMA 500MG

850MG

1GM

MYLAN PHARMS INC 500MG

850MG

1GM

TABLET, EXTENDED RELEASE; ORAL METFORMIN HYDROCHLORIDE

A090888

A090888

A090888

A075969

A075969

A075969

001

002

003

001

002

003

Mar 12, 2012

Mar 12, 2012

Mar 12, 2012

Jan 29, 2002

Jan 29, 2002

Jan 29, 2002

Feb

Feb

Feb

Sep

Sep

Sep

NEWA

NEWA

NEWA

CAHN

CAHN

CAHN

>A>

AB1

AB

AB1

AB2

AB

AB1

AB

AUROBINDO PHARMA LTD

INVENTIA HLTHCARE

MYLAN PHARMS INC

NOSTRUM PHARMS LLC

@ RANBAXY LABS LTD

@

500MG

750MG

500MG

500MG

1GM

500MG

750MG

500MG

750MG

A079118

A079118

A201991

A200690

A200690

A076756

A076756

A076413

A077211

001

002

001

001

002

001

002

001

001

Jul 20, 2012

Jul 20, 2012

Jan 18, 2012

Aug 01, 2012

Aug 01, 2012

Jul 26, 2006

Dec 12, 2011

Jun 18, 2004

Jun 29, 2005

Jul

Jul

Jan

Jul

Jul

Oct

Nov

Apr

Apr

NEWA

NEWA

NEWA

NEWA

NEWA

CAHN

NEWA

DISC

DISC

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET; ORAL ACTOPLUS MET

AB

AB

TAKEDA PHARMS USA 500MG;EQ 15MG BASE

+ 850MG;EQ 15MG BASE

TABLET, EXTENDED RELEASE; ORAL ACTOPLUS MET XR

N021842

N021842

001

002

Aug 29, 2005

Aug 29, 2005

Aug

Aug

CAHN

CAHN

+

TAKEDA PHARMS USA 1GM;EQ 15MG BASE

1GM;EQ 30MG BASE

N022024

N022024

001

002

May 12, 2009

May 12, 2009

Aug

Aug

CAHN

CAHN

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL KOMBIGLYZE XR

BRISTOL MYERS SQUIBB 500MG;EQ 5MG BASE

1GM;EQ 2.5MG BASE

N200678

N200678

001

003

Nov 05, 2010

Nov 05, 2010

Apr

Apr

CAIN

CAIN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 86: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-77

TABLET, EXTENDED RELEASE; ORAL KOMBIGLYZE XR

+ BRISTOL MYERS SQUIBB 1GM;EQ 5MG BASE N200678 002 Nov 05, 2010 Apr CAIN

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

TABLET; ORAL JANUMET

MERCK SHARP DOHME 500MG;EQ 50MG BASE

+ 1GM;EQ 50MG BASE

TABLET, EXTENDED RELEASE; ORAL JANUMET XR

MERCK SHARP DOHME 500MG;EQ 50MG BASE

1GM;EQ 50MG BASE

+ 1GM;EQ 100MG BASE

N022044

N022044

N202270

N202270

N202270

001

002

001

002

003

Mar 30, 2007

Mar 30, 2007

Feb 02, 2012

Feb 02, 2012

Feb 02, 2012

May

May

Feb

Feb

Feb

CAHN

CAHN

NEWA

NEWA

NEWA

METHIMAZOLE

AB

AB

TABLET; ORAL METHIMAZOLE

BOCA PHARMA 5MG

10MG

A202068

A202068

001

002

Mar 07, 2012

Mar 07, 2012

Feb

Feb

NEWA

NEWA

METHOCARBAMOL

AA

TABLET; ORAL METHOCARBAMOL

SOLCO HLTHCARE 500MG A086989 001 Mar CMFD

AA 750MG A086988 001 Mar CMFD

METHOTREXATE SODIUM

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

INJECTABLE; INJECTION METHOTREXATE PRESERVATIVE FREE

APP PHARMS LLC EQ 1GM BASE/VIAL

PHARMACHEMIE BV EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

METHOTREXATE SODIUM + BEDFORD EQ 100MG BASE/4ML (EQ 25MG

BASE/ML)METHOTREXATE SODIUM PRESERVATIVE FREE

+ MYLAN INSTITUTIONAL EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

+ EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

+ EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

ONCO THERAPIES LTD EQ 50MG BASE/2ML (EQ 25MG BASE/ML)EQ 100MG BASE/4ML (EQ 25MG BASE/ML)EQ 200MG BASE/8ML (EQ 25MG BASE/ML)EQ 250MG BASE/10ML (EQ 25MG BASE/ML)EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

A040266

A200171

A089341

A040767

A040768

A040716

A201529

A201529

A201529

A201529

A201530

001

001

001

001

001

001

001

002

003

004

001

Feb 26, 1999

Feb 27, 2012

Sep 16, 1986

Apr 30, 2007

Apr 30, 2007

Apr 30, 2007

Mar 29, 2012

Mar 29, 2012

Mar 29, 2012

Mar 29, 2012

Mar 29, 2012

Jan

Feb

Feb

Feb

Sep

Sep

Mar

Mar

Mar

Mar

Mar

CMFD

NEWA

CTEC

CAHN

CAHN

CAHN

NEWA

NEWA

NEWA

NEWA

NEWA

METHSCOPOLAMINE BROMIDE

AA

AA

TABLET; ORAL METHSCOPOLAMINE BROMIDE

BAYSHORE PHARMS LLC 2.5MG

5MG

A200602

A200602

001

002

Sep 24, 2012

Sep 24, 2012

Sep

Sep

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 87: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-78

METHYCLOTHIAZIDE

TABLET; ORAL ENDURON @ ABBOTT LABS PHARM 2.5MG N012524 001 Mar DISC

@ 5MG N012524 004 Mar DISC

METHYCLOTHIAZIDE AB + MYLAN PHARMS INC 5MG A087672 001 Aug 17, 1982 Mar CRLD

METHYLDOPATE HYDROCHLORIDE

INJECTABLE; INJECTION METHYLDOPATE HYDROCHLORIDE @ TEVA PARENTERAL 50MG/ML A072974 001 Nov 22, 1991 Mar DISC

METHYLERGONOVINE MALEATE

INJECTABLE; INJECTION METHERGINE

AP + US PHARMS HOLDINGS I 0.2MG/ML N006035 004 Sep CAHN

TABLET; ORAL METHERGINE

AB + US PHARMS HOLDINGS I 0.2MG N006035 003 Sep CAHN

METHYLNALTREXONE BROMIDE

INJECTABLE; SUBCUTANEOUS RELISTOR

SALIX PHARMS 8MG/0.4ML N021964 002 Sep 27, 2010 May CAHN

+ 12MG/0.6ML (12MG/0.6ML) N021964 003 Apr 24, 2008 Jun NEWA

SOLUTION; SUBCUTANEOUS RELISTOR

+ SALIX PHARMS 12MG/0.6ML (12MG/0.6ML) N021964 001 Apr 24, 2008 May CAHN

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL METADATE CD

AB UCB INC 10MG N021259 003 May 27, 2003 Jul CFTG

AB2 20MG N021259 001 Apr 03, 2001 Jul CFTG

AB2 30MG N021259 002 Jun 19, 2003 Jul CFTG

AB2 40MG N021259 004 Feb 19, 2006 Jul CFTG

AB 50MG N021259 005 Feb 19, 2006 Jul CFTG

AB + 60MG N021259 006 Feb 19, 2006 Jul CFTG

METHYLPHENIDATE HYDROCHLORIDE AB1 ACTAVIS 20MG A078458 001 Dec 01, 2011 Jul CTEC

AB1 30MG A078458 002 Dec 01, 2011 Jul CTEC

AB1 40MG A078458 003 Dec 01, 2011 Jul CTEC

AB1 BARR LABS INC 20MG A079031 001 Jul 13, 2012 Jul CTEC

AB 20MG A079031 001 Jul 13, 2012 Jun NEWA

AB1 30MG A079031 002 Jul 13, 2012 Jul CTEC

AB 30MG A079031 002 Jul 13, 2012 Jun NEWA

AB1 40MG A079031 003 Jul 13, 2012 Jul CTEC

AB 40MG A079031 003 Jul 13, 2012 Jun NEWA

AB TEVA PHARMS 10MG A077707 001 Jul 19, 2012 Jul NEWA

AB2 20MG A077707 002 Jul 19, 2012 Jul NEWA

AB2 30MG A077707 003 Jul 19, 2012 Jul NEWA

AB2 40MG A078873 001 Jul 19, 2012 Jul NEWA

AB 50MG A078873 002 Jul 19, 2012 Jul NEWA

AB 60MG A078873 003 Jul 19, 2012 Jul NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 88: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-79

AB1

AB1

AB1

AB

AB

AB

CAPSULE, EXTENDED RELEASE; ORAL RITALIN LA

NOVARTIS 20MG

30MG

+ 40MG

FOR SUSPENSION, EXTENDED RELEASE; ORAL QUILLIVANT XR

+ NEXTWAVE PHARMS 5MG/ML

TABLET; ORAL METHYLPHENIDATE HYDROCHLORIDE

SUN PHARM INDS INC 5MG

10MG

20MG

TABLET, EXTENDED RELEASE; ORAL METADATE ER @ UCB INC 10MG

N021284

N021284

N021284

N202100

A090710

A090710

A090710

A040306

001

002

003

001

001

002

003

001

Jun 05, 2002

Jun 05, 2002

Jun 05, 2002

Sep 27, 2012

Mar 15, 2012

Mar 15, 2012

Mar 15, 2012

Oct 20, 1999

Jul

Jul

Jul

Sep

Feb

Feb

Feb

Jul

CTEC

CTEC

CTEC

NEWA

NEWA

NEWA

NEWA

DISC

METHYLPREDNISOLONE SODIUM SUCCINATE

AP

AP

INJECTABLE; INJECTION A-METHAPRED

HOSPIRA INC EQ 40MG BASE/VIAL

EQ 125MG BASE/VIAL

METHYLPREDNISOLONE SODIUM SUCCINATE @ BEDFORD LABS EQ 40MG BASE/VIAL

@ EQ 125MG BASE/VIAL

@ EQ 500MG BASE/VIAL

@ EQ 500MG BASE/VIAL

@ EQ 1GM BASE/VIAL

@ EQ 1GM BASE/VIAL

@ TEVA PARENTERAL EQ 125MG BASE/VIAL

A040793

A040827

A040662

A040641

A040641

A040709

A040641

A040709

A081266

001

001

001

002

003

001

004

002

001

Nov 25, 2008

Nov 25, 2008

Feb 21, 2007

Feb 21, 2007

Feb 21, 2007

Feb 21, 2007

Feb 21, 2007

Feb 21, 2007

Nov 30, 1992

Aug

Aug

Jun

Jun

Jun

Jun

Jun

Jun

Mar

CAHN

CAHN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

METOCLOPRAMIDE HYDROCHLORIDE

>D>

>A> AP

AB

INJECTABLE; INJECTION METOCLOPRAMIDE HYDROCHLORIDE @ TEVA PARENTERAL EQ 5MG BASE/ML

EQ 5MG BASE/ML

@ EQ 5MG BASE/ML

TABLET; ORAL METOCLOPRAMIDE HYDROCHLORIDE

PAR PHARM INC EQ 10MG BASE

A073135

A073135

A073135

A070581

001

001

001

001

Nov 27, 1991

Nov 27, 1991

Nov 27, 1991

Oct 17, 1985

Nov

Nov

Jan

Oct

CMFD

CMFD

DISC

CAHN

METOPROLOL SUCCINATE

AB

AB

AB

AB

TABLET, EXTENDED RELEASE; ORAL METOPROLOL SUCCINATE

DR REDDYS LABS LTD EQ 25MG TARTRATE

EQ 50MG TARTRATE

@ NESHER PHARMS EQ 100MG TARTRATE

@ EQ 200MG TARTRATE

REDDYS EQ 100MG BASE

EQ 200MG BASE

@ SANDOZ EQ 25MG TARTRATE

@ EQ 50MG TARTRATE

@ EQ 100MG TARTRATE

@ EQ 200MG TARTRATE

A090617

A090617

A076640

A076640

A078889

A078889

A076969

A076969

A076969

A076969

001

002

002

001

001

002

001

002

003

004

Aug 01, 2012

Aug 01, 2012

May 18, 2007

May 18, 2007

Aug 15, 2012

Aug 15, 2012

Jul 31, 2006

May 18, 2007

Mar 20, 2008

Mar 20, 2008

Jul

Jul

Jun

Jun

Jul

Jul

Aug

Aug

Aug

Aug

NEWA

NEWA

DISC

DISC

NEWA

NEWA

DISC

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 89: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-80

METOPROLOL TARTRATE

TABLET; ORAL LOPRESSOR

AB

AB

US PHARMS HOLDINGS I 50MG

100MG

N017963

N017963

001

002

Sep

Sep

CAHN

CAHN

METRONIDAZOLE

CREAM; TOPICAL METRONIDAZOLE

AB FOUGERA PHARMS

NORITATE

0.75% A076408 001 May 28, 2004 Jan CAHN

>A>

>D>

+ VALEANT BERMUDA

+ VALEANT INTL

+

GEL; TOPICAL METRONIDAZOLE

1%

1%

1%

N020743

N020743

N020743

001

001

001

Sep 26, 1997

Sep 26, 1997

Sep 26, 1997

Nov

Nov

Apr

CAHN

CAHN

CAHN

AB FOUGERA PHARMS

INJECTABLE; INJECTION METRONIDAZOLE

0.75% A077018 001 Jun 06, 2006 Jan CAHN

@ HIKMA MAPLE

LOTION; TOPICAL METRONIDAZOLE

500MG/100ML N018907 001 Mar 30, 1984 Sep CAHN

AB FOUGERA PHARMS 0.75% A077197 001 May 24, 2006 Jan CAHN

METYRAPONE

CAPSULE; ORAL METOPIRONE

+ HRA PHARMA

TABLET; ORAL METOPIRONE

250MG N012911 002 Aug 09, 1996 Jun CAHN

@ HRA PHARMA 250MG N012911 001 Jun CAHN

METYROSINE

CAPSULE; ORAL DEMSER

+ BIOVAIL TECHNOLOGIES 250MG N017871 001 May CAHN

MICONAZOLE

TABLET; BUCCAL ORAVIG

+ VESTIQ PHARMS 50MG N022404 001 Apr 16, 2010 Sep CAHN

MIDAZOLAM HYDROCHLORIDE

INJECTABLE; INJECTION MIDAZOLAM HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

GLAND PHARMA LTD

HIKMA MAPLE

EQ 1MG BASE/ML

EQ 5MG BASE/ML

EQ 1MG BASE/ML

EQ 1MG BASE/ML

EQ 5MG BASE/ML

EQ 5MG BASE/ML

A090696

A090850

A075243

A075324

A075243

A075324

001

001

001

001

002

002

Feb 29, 2012

Jan 25, 2012

Jun 20, 2000

Jun 20, 2000

Jun 20, 2000

Jun 20, 2000

Feb

Jan

Sep

Sep

Sep

Sep

NEWA

NEWA

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 90: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-81

MIDODRINE HYDROCHLORIDE

>A> TABLET; ORAL

PROAMATINE >A>

>A>

>A>

>A>

>A>

>A>

>A>

>A>

>A>

>D>

>A>

>A>

>A>

>A>

>A>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

+

+

@ SHIRE LLC

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

5MG

5MG

5MG

10MG

10MG

10MG

10MG

10MG

10MG

10MG

10MG

10MG

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

N019815

001

001

001

001

001

001

001

001

001

001

002

002

002

003

003

003

003

003

003

003

003

003

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Sep 06, 1996

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Mar 20, 2002

Nov

Nov

Nov

Nov

Nov

Nov

Nov

Nov

Nov

Jan

Nov

Nov

Jan

Nov

Nov

Nov

Nov

Nov

Nov

Nov

Nov

Jan

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CAHN

DISC

DISC

CAHN

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CAHN

MIFEPRISTONE

TABLET; ORAL KORLYM

+ CORCEPT THERAP 300MG N202107 001 Feb 17, 2012 Feb NEWA

MILRINONE LACTATE

INJECTABLE; INJECTION MILRINONE LACTATE

AP HIKMA MAPLE EQ 1MG BASE/ML

@ EQ 1MG BASE/ML

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

A075530

A075852

001

001

May 28, 2002

May 28, 2002

Sep

Sep

CAHN

CAHN

@ HIKMA MAPLE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

A075510 001 May 28, 2002 Sep CAHN

MINOCYCLINE HYDROCHLORIDE

CAPSULE; ORAL MINOCIN

AB

AB

PRECISION DERMAT EQ 50MG BASE

@ EQ 75MG BASE

EQ 100MG BASE

CAPSULE, EXTENDED RELEASE; ORAL XIMINO

N050649

N050649

N050649

001

003

002

May 31, 1990

Feb 12, 2001

May 31, 1990

May

May

May

CAHN

CAHN

CAHN

+

RANBAXY LABS LTD EQ 45MG BASE

EQ 67.5MG BASE

EQ 90MG BASE

EQ 112.5MG BASE

EQ 135MG BASE

N201922

N201922

N201922

N201922

N201922

001

002

003

004

005

Jul 11, 2012

Jul 11, 2012

Jul 11, 2012

Jul 11, 2012

Jul 11, 2012

Jul

Jul

Jul

Jul

Jul

NEWA

NEWA

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 91: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-82

>D>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

INJECTABLE; INJECTION MINOCIN

+ PRECISION DERMAT EQ 100MG BASE/VIAL

+ EQ 100MG BASE/VIAL

+ REMPEX PHARMS INC EQ 100MG BASE/VIAL

SUSPENSION; ORAL MINOCIN @ PRECISION DERMAT EQ 50MG BASE/5ML

TABLET, EXTENDED RELEASE; ORAL MINOCYCLINE HYDROCHLORIDE

AUROBINDO PHARMA LTD EQ 45MG BASE

EQ 90MG BASE

EQ 135MG BASE

BARR LABS INC EQ 65MG BASE

EQ 115MG BASE

MYLAN PHARMS INC EQ 45MG BASE

EQ 90MG BASE

EQ 135MG BASE

SOLODYN MEDICIS EQ 65MG BASE

EQ 115MG BASE

N050444

N050444

N050444

N050445

A202261

A202261

A202261

A065485

A065485

A090911

A090911

A090911

N050808

N050808

001

001

001

001

001

003

005

004

005

001

002

003

004

005

Nov 19, 2012

Nov 19, 2012

Nov 19, 2012

May 18, 2012

May 18, 2012

Jul 20, 2010

Jul 20, 2010

Jul 20, 2010

Jul 23, 2009

Jul 23, 2009

Nov

May

Nov

May

Nov

Nov

Nov

Sep

Sep

Sep

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

NEWA

NEWA

NEWA

NEWA

NEWA

CAHN

CAHN

CAHN

CFTG

CFTG

MIRABEGRON

TABLET, EXTENDED RELEASE; ORAL MYRBETRIQ

APGDI 25MG

+ 50MG

N202611

N202611

001

002

Jun 28, 2012

Jun 28, 2012

Jun

Jun

NEWA

NEWA

MIRTAZAPINE

AB

AB

AB

TABLET; ORAL MIRTAZAPINE

MYLAN PHARMS INC 15MG

30MG

45MG

A076176

A076176

A076176

001

002

003

Jun 19, 2003

Jun 19, 2003

Jun 19, 2003

Sep

Sep

Sep

CAHN

CAHN

CAHN

MISOPROSTOL

AB

AB

TABLET; ORAL MISOPROSTOL

NOVEL LABS INC 0.1MG

0.2MG

A091667

A091667

001

002

Jul 25, 2012

Jul 25, 2012

Jul

Jul

NEWA

NEWA

MITOMYCIN

AP

AP

FOR SOLUTION; TOPICAL MITOSOL

+ MOBIUS THERAP

INJECTABLE; INJECTION MITOMYCIN

HIKMA MAPLE

0.2MG/VIAL

5MG/VIAL

20MG/VIAL

N022572

A064180

A064180

001

001

002

Feb 07, 2012

Dec 23, 1999

Dec 23, 1999

Feb

Sep

Sep

NEWA

CAHN

CAHN

MITOXANTRONE

>A> AP

INJECTABLE; INJECTION MITOXANTRONE HYDROCHLORIDE

ONCO THERAPIES LTD EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

A201014 001 Dec 11, 2012 Nov NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 92: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-83

MITOXANTRONE HYDROCHLORIDE

INJECTABLE; INJECTION MITOXANTRONE HYDROCHLORIDE @ FRESENIUS KABI ONCOL EQ 20MG BASE/10ML (EQ 2MG

BASE/ML)@ EQ 25MG BASE/12.5ML (EQ 2MG

BASE/ML)@ EQ 30MG BASE/15ML (EQ 2MG

BASE/ML)

A078606

A078606

A078606

001

002

003

May 14, 2008

May 14, 2008

May 14, 2008

Jun

Jun

Jun

DISC

DISC

DISC

MIVACURIUM CHLORIDE

INJECTABLE; INJECTION MIVACURIUM CHLORIDE @ STRIDES ARCOLAB LTD EQ 2MG BASE/ML A078562 001 Apr 30, 2009 Jun CAHN

MODAFINIL

TABLET; ORAL MODAFINIL

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

ALEMBIC LTD

AUROBINDO PHARMA LTD

CARLSBAD

HIKMA PHARMS

MYLAN PHARMS INC

ORCHID HLTHCARE

PROVIGIL

100MG

200MG

100MG

200MG

100MG

200MG

100MG

200MG

100MG

200MG

100MG

200MG

A202700

A202700

A202566

A202566

A076715

A076715

A090543

A090543

A076594

A076594

A078963

A078963

001

002

001

002

001

002

001

002

001

002

001

002

Oct 18, 2012

Oct 18, 2012

Sep 27, 2012

Sep 27, 2012

Nov 01, 2012

Nov 01, 2012

Sep 26, 2012

Sep 26, 2012

Jul 16, 2012

Jul 16, 2012

Sep 26, 2012

Sep 26, 2012

Oct

Oct

Sep

Sep

Oct

Oct

Sep

Sep

Jun

Jun

Sep

Sep

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB

AB +

CEPHALON 100MG

200MG

N020717

N020717

001

002

Dec 24, 1998

Dec 24, 1998

Jun

Jun

CFTG

CFTG

MOMETASONE FUROATE

CREAM; TOPICAL ELOCON

AB + MERCK SHARP DOHME

MOMETASONE FUROATE

0.1% N019625 001 May 06, 1987 Jun CAHN

AB FOUGERA PHARMS

LOTION; TOPICAL ELOCON

0.1% A076171 001 Apr 08, 2005 Jan CAHN

AB + MERCK SHARP DOHME

MOMETASONE FUROATE

0.1% N019796 001 Mar 30, 1989 Jul CAHN

AB FOUGERA PHARMS

OINTMENT; TOPICAL ELOCON

0.1% A075919 001 Nov 29, 2007 Jan CAHN

AB + MERCK SHARP DOHME

MOMETASONE FUROATE

0.1% N019543 001 Apr 30, 1987 May CAHN

AB FOUGERA PHARMS 0.1% A077061 001 Mar 28, 2005 Jan CAHN

MONTELUKAST SODIUM

GRANULE; ORAL MONTELUKAST SODIUM

AB

AB

DR REDDYS LABS LTD

TEVA PHARMS

EQ 4MG BASE/PACKET

EQ 4MG BASE/PACKET

A202906

A090955

001

001

Sep 17, 2012

Aug 03, 2012

Sep

Jul

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 93: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-84

GRANULE; ORAL SINGULAIR

AB + MERCK EQ 4MG BASE/PACKET N021409 001 Jul 26, 2002 Jul CFTG

TABLET; ORAL MONTELUKAST SODIUM

AB ACCORD HLTHCARE EQ 10MG BASE A202717 001 Sep 21, 2012 Sep NEWA

AB APOTEX CORP EQ 10MG BASE A201294 001 Aug 03, 2012 Jul NEWA

AB AUROBINDO PHARMA LTD EQ 10MG BASE A202468 001 Aug 03, 2012 Jul NEWA

AB DR REDDYS LABS LTD EQ 10MG BASE A201582 001 Aug 06, 2012 Jul NEWA

AB ENDO PHARMS EQ 10MG BASE A091576 001 Aug 03, 2012 Jul NEWA

AB GLENMARK GENERICS EQ 10MG BASE A090926 001 Aug 03, 2012 Jul NEWA

AB

AB

KUDCO IRELAND

MYLAN PHARMS INC

EQ 10MG BASE

EQ 10MG BASE

A201522

A079103

001

001

Aug 03, 2012

Aug 03, 2012

Jul

Jul

NEWA

NEWA

AB ROXANE EQ 10MG BASE A090655 001 Aug 03, 2012 Jul NEWA

AB SANDOZ INC EQ 10MG BASE A200889 001 Aug 03, 2012 Jul NEWA

AB TEVA PHARMS EQ 10MG BASE A078605 001 Aug 03, 2012 Jul NEWA

AB TORRENT PHARMS LTD EQ 10MG BASE A201515 001 Aug 03, 2012 Jul NEWA

AB VINTAGE PHARMS LLC EQ 10MG BASE A091576 001 Aug 03, 2012 Oct CAHN

SINGULAIR AB + MERCK EQ 10MG BASE N020829 002 Feb 20, 1998 Jul CFTG

TABLET, CHEWABLE; ORAL MONTELUKAST SODIUM

AB APOTEX INC EQ 4MG BASE A201508 001 Aug 03, 2012 Jul NEWA

AB EQ 5MG BASE A201508 002 Aug 03, 2012 Jul NEWA

AB AUROBINDO PHARMA LTD EQ 4MG BASE A202096 001 Aug 03, 2012 Jul NEWA

AB

AB DR REDDYS LABS LTD

EQ 5MG BASE

EQ 4MG BASE

A202096

A201581

002

001

Aug 03, 2012

Aug 06, 2012

Jul

Jul

NEWA

NEWA

AB EQ 5MG BASE A201581 002 Aug 06, 2012 Jul NEWA

AB ENDO PHARMS EQ 4MG BASE A091588 001 Aug 03, 2012 Jul NEWA

AB EQ 5MG BASE A091588 002 Aug 03, 2012 Jul NEWA

AB KUDCO IRELAND EQ 4MG BASE A200405 001 Aug 03, 2012 Jul NEWA

AB EQ 5MG BASE A200405 002 Aug 03, 2012 Jul NEWA

AB

AB

MYLAN PHARMS INC EQ 4MG BASE

EQ 5MG BASE

A079142

A079142

001

002

Aug 03, 2012

Aug 03, 2012

Jul

Jul

NEWA

NEWA

AB ROXANE EQ 4MG BASE A091128 001 Aug 03, 2012 Jul NEWA

AB EQ 5MG BASE A091128 002 Aug 03, 2012 Jul NEWA

AB SANDOZ INC EQ 4MG BASE A091414 001 Aug 03, 2012 Jul NEWA

AB EQ 5MG BASE A091414 002 Aug 03, 2012 Jul NEWA

AB TEVA PHARMS EQ 4MG BASE A078723 001 Aug 03, 2012 Jul NEWA

AB

AB TORRENT PHARMS LTD

EQ 5MG BASE

EQ 4MG BASE

A078723

A090984

002

001

Aug 03, 2012

Aug 03, 2012

Jul

Jul

NEWA

NEWA

AB EQ 5MG BASE A090984 002 Aug 03, 2012 Jul NEWA

AB VINTAGE PHARMS LLC EQ 4MG BASE A091588 001 Aug 03, 2012 Oct CAHN

AB EQ 5MG BASE A091588 002 Aug 03, 2012 Oct CAHN

SINGULAIR AB MERCK EQ 4MG BASE N020830 002 Mar 03, 2000 Jul CFTG

AB + EQ 5MG BASE N020830 001 Feb 20, 1998 Jul CFTG

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE; ORAL KADIAN

ACTAVIS ELIZABETH 40MG N020616 009 Jul 09, 2012 Jul NEWA

70MG N020616 010 Jul 09, 2012 Jul NEWA

130MG N020616 011 Jul 09, 2012 Jul NEWA

150MG N020616 012 Jul 09, 2012 Jul NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 94: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-85

CAPSULE, EXTENDED RELEASE; ORAL MORPHINE SULFATE

>A> AB PAR PHARM INC 20MG A200812 001 Nov 10, 2011 Nov CAHN

>A> AB 30MG A200812 002 Nov 10, 2011 Nov CAHN

>A> AB 50MG A200812 003 Nov 10, 2011 Nov CAHN

>A> AB 60MG A200812 004 Nov 10, 2011 Nov CAHN

>A> AB 80MG A200812 005 Nov 10, 2011 Nov CAHN

>A> AB 100MG A200812 006 Nov 10, 2011 Nov CAHN

>D> AB WATSON LABS 20MG A200812 001 Nov 10, 2011 Nov CAHN

>D> AB 30MG A200812 002 Nov 10, 2011 Nov CAHN

>D> AB 50MG A200812 003 Nov 10, 2011 Nov CAHN

>D> AB 60MG A200812 004 Nov 10, 2011 Nov CAHN

>D> AB 80MG A200812 005 Nov 10, 2011 Nov CAHN

>D> AB 100MG A200812 006 Nov 10, 2011 Nov CAHN

INJECTABLE; INJECTION DURAMORPH PF

AP + HIKMA MAPLE 0.5MG/ML N018565 001 Sep 18, 1984 Jun CAHN

AP + 1MG/ML N018565 002 Sep 18, 1984 Jun CAHN

INFUMORPH + HIKMA MAPLE 10MG/ML N018565 003 Jul 19, 1991 Jun CAHN

+ 25MG/ML N018565 004 Jul 19, 1991 Jun CAHN

INJECTABLE, LIPOSOMAL; EPIDURAL DEPODUR @ PACIRA PHARMS INC 10MG/ML (10MG/ML) N021671 001 May 18, 2004 May CAHN

@ 15MG/1.5ML (10MG/ML) N021671 002 May 18, 2004 May CAHN

@ 20MG/2ML (10MG/ML) N021671 003 May 18, 2004 May CAHN

SOLUTION; ORAL MORPHINE SULFATE

AA PADDOCK LLC 100MG/5ML A201574 001 Aug 06, 2012 Jul NEWA

TABLET, EXTENDED RELEASE; ORAL MORPHINE SULFATE

AB RANBAXY LABS LTD 15MG A078761 001 May 11, 2012 Apr NEWA

AB

AB

30MG

60MG

A078761

A078761

002

003

May 11, 2012

May 11, 2012

Apr

Apr

NEWA

NEWA

AB 100MG A078761 004 May 11, 2012 Apr NEWA

AB 200MG A078761 005 May 11, 2012 Apr NEWA

AB

AB

AB

VINTAGE PHARMS LLC 15MG

30MG

60MG

A075295

A075295

A075295

001

002

003

Oct 28, 1998

Oct 28, 1998

Oct 28, 1998

Sep

Sep

Sep

CAHN

CAHN

CAHN

AB 100MG A075295 004 Sep 15, 2000 Sep CAHN

AB 200MG A075295 005 Sep 15, 2000 Sep CAHN

ORAMORPH SR @ XANODYNE PHARMS INC 15MG N019977 004 Nov 23, 1994 May DISC

@ 30MG

@ 60MG

@ 100MG

N019977

N019977

N019977

001

002

003

Aug 15, 1991

Aug 15, 1991

Aug 15, 1991

May

May

May

DISC

DISC

DISC

MUPIROCIN

OINTMENT; TOPICAL MUPIROCIN

AB FOUGERA PHARMS 2% A065192 001 Nov 30, 2005 Jan CAHN

MYCOPHENOLATE MOFETIL

CAPSULE; ORAL MYCOPHENOLATE MOFETIL

AB VINTAGE PHARMS LLC 250MG A090111 001 Dec 22, 2009 Sep CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 95: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-86

AB

CAPSULE; ORAL MYCOPHENOLATE MOFETIL @ ZYDUS PHARMS USA INC

TABLET; ORAL MYCOPHENOLATE MOFETIL

VINTAGE PHARMS LLC

@ ZYDUS PHARMS USA INC

250MG

500MG

500MG

A065433

A090606

A065477

001

001

001

May 04, 2009

Jul 16, 2010

May 04, 2009

Sep

Sep

Sep

DISC

CAHN

DISC

MYCOPHENOLIC ACID

AB

AB

TABLET, DELAYED RELEASE; ORAL MYCOPHENOLIC ACID

APOTEX INC 180MG

MYFORTIC NOVARTIS 180MG

A091558

N050791

001

001

Aug 21, 2012

Feb 27, 2004

Aug

Aug

NEWA

CFTG

NABUMETONE

AB

AB

AB

AB

TABLET; ORAL NABUMETONE

MYLAN PHARMS INC

PROSAM LABS

500MG

750MG

500MG

750MG

A090516

A090516

A079093

A079093

001

002

001

002

Jul 12, 2010

Jul 12, 2010

Feb 27, 2009

Feb 27, 2009

Sep

Sep

Feb

Feb

CAHN

CAHN

CMFD

CMFD

NAFCILLIN SODIUM

>D>

>D>

>D>

>A>

>A>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

INJECTABLE; INJECTION NAFCILLIN SODIUM

ANTIBIIOTICE

ASTRAL PHARM INDS

SAGENT PHARMS

EQ 1GM BASE

EQ 2GM BASE

EQ 1GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

A090560

A090560

A090582

A090582

A090582

A090582

A090580

A090580

A090582

A090582

A090580

001

002

001

001

002

002

001

001

001

002

001

Oct 03, 2011

Oct 03, 2011

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug 24, 2012

Aug

Aug

Nov

Aug

Nov

Aug

Nov

Aug

Nov

Nov

Nov

CAHN

CAHN

CAHN

NEWA

CAHN

NEWA

CAHN

NEWA

CAHN

CAHN

CAHN

NAFTIFINE HYDROCHLORIDE

CREAM; TOPICAL NAFTIN

+ MERZ PHARMS 2% N019599 002 Jan 13, 2012 Jan NEWA

NALOXONE HYDROCHLORIDE

INJECTABLE; INJECTION NALOXONE @ HIKMA MAPLE

@

@

NALOXONE HYDROCHLORIDE @ HIKMA MAPLE

@

@

@

0.4MG/ML

0.4MG/ML

0.4MG/ML

0.02MG/ML

1MG/ML

1MG/ML

1MG/ML

A070299

A070298

A070496

A071272

A071287

A071273

A071274

001

001

001

001

001

001

001

Sep 24, 1986

Sep 24, 1986

Sep 24, 1986

May 24, 1988

May 24, 1988

May 24, 1988

May 24, 1988

Jun

Jun

Jun

Jun

Jun

Jun

Jun

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 96: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-87

NALTREXONE HYDROCHLORIDE

AB

TABLET; ORAL NALTREXONE HYDROCHLORIDE

SUN PHARMA GLOBAL 50MG A090356 001 Feb 24, 2012 Feb NEWA

NAPROXEN

AB

AB

TABLET, DELAYED RELEASE; ORAL NAPROXEN

MYLAN PHARMS INC 375MG

500MG

A075390

A075390

001

002

Apr 19, 2001

Apr 19, 2001

Sep

Sep

CAHN

CAHN

NAPROXEN SODIUM

AB

AB

TABLET; ORAL ANAPROX

HOFFMANN LA ROCHE

ANAPROX DS + HOFFMANN LA ROCHE

EQ 250MG BASE

EQ 500MG BASE

N018164

N018164

001

003 Sep 30, 1987

May

May

CAHN

CAHN

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

TABLET; ORAL TREXIMET

+ SMITHKLINE BEECHAM 500MG;EQ 85MG BASE N021926 001 Apr 15, 2008 May CAHN

NARATRIPTAN HYDROCHLORIDE

AB

AB

AB

AB

TABLET; ORAL NARATRIPTAN

MYLAN PHARMS INC

ORCHID HLTHCARE

EQ 1MG BASE

EQ 2.5MG BASE

EQ 1MG BASE

EQ 2.5MG BASE

A202431

A202431

A091441

A091441

001

002

001

002

May 31, 2012

May 31, 2012

Apr 30, 2012

Apr 30, 2012

May

May

Apr

Apr

NEWA

NEWA

NEWA

NEWA

NATEGLINIDE

TABLET; ORAL NATEGLINIDE @ TEVA PHARMS

@

60MG

120MG

A077467

A077467

001

002

Sep 09, 2009

Sep 09, 2009

Jul

Jul

DISC

DISC

NEDOCROMIL SODIUM

AT

AT

SOLUTION/DROPS; OPHTHALMICALOCRIL

+ ALLERGAN 2%

NEDOCROMIL SODIUM AKORN 2%

N021009

A090638

001

001

Dec 08, 1999

Aug 22, 2012

Aug

Aug

CFTG

NEWA

NEPAFENAC

SUSPENSION/DROPS; OPHTHALMICNEPAFENAC

+ ALCON RES LTD 0.3% N203491 001 Oct 16, 2012 Oct NEWA

NEVIRAPINE

AA

AA

SUSPENSION; ORAL NEVIRAPINE

AUROBINDO

VIRAMUNE + BOEHRINGER INGELHEIM

50MG/5ML

50MG/5ML

A077702

N020933

001

001

May 22, 2012

Sep 11, 1998

May

May

NEWA

CFTG

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 97: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-88

TABLET; ORAL NEVIRAPINE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

APOTEX INC

AUROBINDO

CIPLA

HETERO LABS LTD III

MICRO LABS LTD

MYLAN LABS

MYLAN PHARMS INC

PRINSTON INC

SCIEGEN PHARMS INC

STRIDES

VIRAMUNE

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

A203021

A077521

A077956

A078584

A203080

A078864

A202523

A078644

A203176

A078195

001

001

001

001

001

001

001

001

001

001

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May 22, 2012

May

May

May

May

May

May

May

May

May

May

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB + BOEHRINGER INGELHEIM 200MG

TABLET, EXTENDED RELEASE; ORAL VIRAMUNE XR

N020636 001 Jun 21, 1996 May CFTG

>A> BOEHRINGER INGELHEIM 100MG N201152 002 Nov 08, 2012 Nov NEWA

NIFEDIPINE

TABLET, EXTENDED RELEASE; ORAL NIFEDIPINE

AB1 ACTAVIS 90MG A077899 003 May 25, 2012 May NEWA

NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE; ORAL MACRODANTIN

AB ALMATICA 25MG N016620 003 Jul CAHN

AB 50MG N016620 001 Jul CAHN

AB + 100MG N016620 002 Jul CAHN

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE; ORAL MACROBID

AB + ALMATICA 75MG;25MG

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)@ RANBAXY LABS LTD 75MG;25MG

N020064

A076951

001

001

Dec 24, 1991

Mar 30, 2005

Jul

Apr

CAHN

DISC

NITROGLYCERIN

FILM, EXTENDED RELEASE; TRANSDERMAL MINITRAN

AB1

AB1

AB1

AB1

MEDICIS

NITROGLYCERIN

0.1MG/HR

0.2MG/HR

0.4MG/HR

0.6MG/HR

A089771

A089772

A089773

A089774

001

001

001

001

Aug 30, 1996

Aug 30, 1996

Aug 30, 1996

Aug 30, 1996

Jul

Jul

Jul

Jul

CAHN

CAHN

CAHN

CAHN

AB2

AB2

AB2

HERCON PHARM

OINTMENT; INTRA-ANAL RECTIV

0.2MG/HR

0.4MG/HR

0.6MG/HR

A089884

A089885

A089886

001

001

001

Oct 30, 1998

Oct 30, 1998

Oct 30, 1998

Oct

Oct

Oct

CAHN

CAHN

CAHN

+ APTALIS PHARMA 0.4% N021359 001 Jun 21, 2011 Jan CAHN

NIZATIDINE

CAPSULE; ORAL AXID @ SMITHKLINE BEECHAM 150MG N019508 001 Apr 12, 1988 Mar DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 98: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-89

CAPSULE; ORAL AXID @ SMITHKLINE BEECHAM

NIZATIDINE

300MG N019508 002 Apr 12, 1988 Mar DISC

AB +

@ MYLAN PHARMS INC

@

150MG

300MG

300MG

A075934

A075806

A075934

001

002

002

Jul 09, 2002

Jul 05, 2002

Jul 09, 2002

Apr

Apr

Apr

DISC

CRLD

DISC

NOREPINEPHRINE BITARTRATE

INJECTABLE; INJECTION NOREPINEPHRINE BITARTRATE

AP

AP

CLARIS LIFESCIENCES

SINTETICA

EQ 1MG BASE/ML

EQ 1MG BASE/ML

A040859

A040859

001

001

Mar 27, 2012

Mar 27, 2012

May

Mar

CAHN

NEWA

NORETHINDRONE ACETATE

TABLET; ORAL NORETHIDRONE ACETATE

AB AMNEAL PHARMS 5MG A200275 001 Jul 30, 2012 Jul NEWA

NYSTATIN

CREAM; TOPICAL NYSTATIN

AT

AT

FOUGERA PHARMS

+ TARO

OINTMENT; TOPICAL NYSTATIN

100,000 UNITS/GM

100,000 UNITS/GM

A062129

A064022

001

001 Jan 29, 1993

Jan

Aug

CAHN

CRLD

AT + FOUGERA PHARMS

POWDER; TOPICAL NYSTATIN

100,000 UNITS/GM A062124 002 Sep 23, 1982 Jan CAHN

@ NESHER PHARMS

TABLET; ORAL NYSTATIN

100,000 UNITS/GM A065321 001 Aug 18, 2006 Jun DISC

AA HERITAGE PHARMS INC 500,000 UNITS A062474 001 Dec 22, 1983 Oct CMFD

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL MYKACET @ G AND W LABS INC

OINTMENT; TOPICAL MYKACET

100,000 UNITS/GM;0.1% A062367 001 May 28, 1985 Jun CAHN

@ G AND W LABS INC 100,000 UNITS/GM;0.1% A062733 001 Mar 09, 1987 Jun CAHN

OFLOXACIN

SOLUTION/DROPS; OPHTHALMICOFLOXACIN @ SANDOZ

TABLET; ORAL OFLOXACIN

0.3% A076848 001 Nov 25, 2008 Aug DISC

@ RANBAXY LABS LTD

@

@

200MG

300MG

400MG

A076220

A076220

A076220

001

002

003

Sep 02, 2003

Sep 02, 2003

Sep 02, 2003

Apr

Apr

Apr

DISC

DISC

DISC

OLANZAPINE

INJECTABLE; INTRAMUSCULAR OLANZAPINE

AP LUITPOLD 10MG/VIAL A201741 001 Mar 20, 2012 Sep CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 99: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-90

INJECTABLE; INTRAMUSCULAR OLANZAPINE

AP

AP

PHARMAFORCE

SANDOZ INC

10MG/VIAL

10MG/VIAL

001 A201741

001 A201588

MarMar 20, 2012

MarOct 24, 2011

NEWA

CAHN

TABLET; ORAL OLANZAPINE

AB APOTEX INC 2.5MG 001 A090798 AprApr 23, 2012 NEWA

AB

AB

AB

5MG

7.5MG

10MG

002 A090798

003 A090798

004 A090798

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

NEWA

NEWA

NEWA

AB 15MG 005 A090798 AprApr 23, 2012 NEWA

AB

AB

AB

AB

AB

AB

AUROBINDO PHARMA LTD

20MG

2.5MG

5MG

7.5MG

10MG

15MG

006 A090798

001 A202050

002 A202050

003 A202050

004 A202050

005 A202050

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB 20MG 006 A202050 AprApr 23, 2012 NEWA

AB

AB

AB

AB

AB

AB

DR REDDYS LABS LTD

MYLAN

2.5MG

5MG

7.5MG

10MG

15MG

2.5MG

001 A076255

002 A076255

003 A076255

004 A076255

001 A076133

001 A076866

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB 5MG 002 A076866 AprApr 23, 2012 NEWA

AB

AB

AB

AB

AB

AB

ORCHID HLTHCARE

7.5MG

10MG

15MG

20MG

2.5MG

5MG

003 A076866

004 A076866

005 A076866

006 A076866

001 A202287

002 A202287

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB 7.5MG 003 A202287 AprApr 23, 2012 NEWA

AB

AB

AB

AB SUN PHARM INDS

10MG

15MG

20MG

2.5MG

004 A202287

005 A202287

006 A202287

001 A091038

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

AprApr 23, 2012

NEWA

NEWA

NEWA

NEWA

AB 5MG 002 A091038 AprApr 23, 2012 NEWA

AB 7.5MG 003 A091038 AprApr 23, 2012 NEWA

AB 10MG 004 A091038 AprApr 23, 2012 NEWA

AB

AB

15MG

20MG

005 A091038

006 A091038

AprApr 23, 2012

AprApr 23, 2012

NEWA

NEWA

AB TORRENT PHARMS LTD 2.5MG 001 A091434 AprApr 23, 2012 NEWA

AB 5MG 002 A091434 AprApr 23, 2012 NEWA

AB 7.5MG 003 A091434 AprApr 23, 2012 NEWA

AB 10MG 004 A091434 AprApr 23, 2012 NEWA

AB 15MG 005 A091434 AprApr 23, 2012 NEWA

AB 20MG 006 A091434 AprApr 23, 2012 NEWA

TABLET, ORALLY DISINTEGRATING; ORAL OLANZAPINE

AB BARR LABS INC 5MG 001 A077243 JanJan 30, 2012 NEWA

AB 10MG 002 A077243 JanJan 30, 2012 NEWA

AB 15MG 003 A077243 JanJan 30, 2012 NEWA

AB 20MG 004 A077243 JanJan 30, 2012 NEWA

AB

AB

JUBILANT ORGANOSYS 5MG

10MG

001 A200221

002 A200221

AugSep 12, 2012

AugSep 12, 2012

NEWA

NEWA

AB 15MG 003 A200221 AugSep 12, 2012 NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 100: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-91

AB

AB

AB

AB

AB

TABLET, ORALLY DISINTEGRATING; ORAL OLANZAPINE

JUBILANT ORGANOSYS 20MG

SUN PHARM INDS 5MG

10MG

15MG

20MG

A200221

A090881

A090881

A090881

A090881

004

001

002

003

004

Sep 12, 2012

Feb 28, 2012

Feb 28, 2012

Feb 28, 2012

Feb 28, 2012

Aug

Feb

Feb

Feb

Feb

NEWA

NEWA

NEWA

NEWA

NEWA

OMACETAXINE MEPESUCCINATE

POWDER; SUBCUTANEOUS SYNRIBO

+ IVAX INTL 3.5MG/VIAL N203585 001 Oct 26, 2012 Oct NEWA

OMEPRAZOLE

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

CAPSULE, DELAYED REL PELLETS; ORAL OMEPRAZOLE

DR REDDYS LABS LTD 10MG

20MG

SANDOZ 10MG

20MG

ZYDUS PHARMS USA INC 10MG

20MG

40MG

A078490

A078490

A075757

A075757

A091352

A091352

A091352

002

003

001

002

001

002

003

Mar 16, 2009

Mar 16, 2009

Jan 28, 2003

Jan 28, 2003

Nov 19, 2012

Nov 19, 2012

Nov 19, 2012

Apr

Apr

Aug

Aug

Nov

Nov

Nov

NEWA

NEWA

CAHN

CAHN

NEWA

NEWA

NEWA

ONDANSETRON

FILM; ORAL ZUPLENZ

VESTIQ PHARMS 4MG

+ 8MG

TABLET, ORALLY DISINTEGRATING; ORAL ONDANSETRON @ NESHER PHARMS 4MG

@ 8MG

@ PAR PHARM 4MG

@ 8MG

@ 16MG

@ 24MG

N022524

N022524

A077717

A077717

A076506

A076506

A077406

A077406

001

002

001

002

001

002

001

002

Jul 02, 2010

Jul 02, 2010

Jun 25, 2007

Jun 25, 2007

Dec 26, 2006

Dec 26, 2006

Dec 26, 2006

Dec 26, 2006

Sep

Sep

Jun

Jun

Aug

Aug

Aug

Aug

CAHN

CAHN

DISC

DISC

DISC

DISC

DISC

DISC

ONDANSETRON HYDROCHLORIDE

AP

AP

AP

INJECTABLE; INJECTION ONDANSETRON HYDROCHLORIDE

GLAND PHARMA LTD EQ 2MG BASE/ML 001 A090648

HIKMA MAPLE EQ 2MG BASE/ML 001 A077365

@ SAGENT PHARMS EQ 2MG BASE/ML 001 A078180

ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER @ BAXTER HLTHCARE EQ 0.64MG BASE/ML 002 N021915

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE HIKMA MAPLE EQ 2MG BASE/ML 001 A077541

TABLET; ORAL ONDANSETRON HYDROCHLORIDE

DR REDDYS LABS LTD EQ 16MG BASE 004 A076183

@ PAR PHARM EQ 4MG BASE 001 A077303

@ EQ 8MG BASE 002 A077303

@ EQ 24MG BASE 004 A077303

@ WEST WARD PHARM CORP EQ 4MG BASE 001 A077545

@ EQ 8MG BASE 002 A077545

Jun 15, 2012

Dec 26, 2006

Mar 26, 2007

Dec 27, 2006

Dec 26, 2006

Dec 26, 2006

Jun 25, 2007

Jun 25, 2007

Jun 25, 2007

Sep 06, 2007

Sep 06, 2007

Jun

Jun

Aug

Sep

Jun

Sep

Aug

Aug

Aug

Sep

Sep

NEWA

CAHN

DISC

DISC

CAHN

NEWA

DISC

DISC

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 101: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-92

TABLET; ORAL ONDANSETRON HYDROCHLORIDE @ WEST WARD PHARM CORP EQ 24MG BASE A077545 003 Sep 06, 2007 Sep DISC

ORPHENADRINE CITRATE

TABLET, EXTENDED RELEASE; ORAL ORPHENADRINE CITRATE

AB

AB

CNTY LINE PHARMS

INVAGEN PHARMS

100MG

100MG

A040249

A091158

001

001

Jan 29, 1999

Jul 27, 2012

Jul

Jul

CAHN

NEWA

OSELTAMIVIR PHOSPHATE

FOR SUSPENSION; ORAL TAMIFLU

+ ROCHE EQ 6MG BASE/ML N021246 002 Mar 21, 2011 Jan CRLD

OXACILLIN SODIUM

INJECTABLE; INJECTION OXACILLIN SODIUM

AP

AP

AP

SAGENT PHARMS EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

A091246

A091246

A091245

001

002

001

Mar 30, 2012

Mar 30, 2012

Mar 30, 2012

Mar

Mar

Mar

NEWA

NEWA

NEWA

OXALIPLATIN

INJECTABLE; IV (INFUSION)OXALIPLATIN

>D>

>A>

>D>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

+

+

@

@

ACTAVIS TOTOWA

ONCO THERAPIES LTD

SANDOZ

TEVA PHARMS

50MG/VIAL

100MG/VIAL

50MG/VIAL

50MG/10ML (5MG/ML)

100MG/20ML (5MG/ML)

100MG/VIAL

50MG/VIAL

50MG/VIAL

100MG/VIAL

100MG/VIAL

50MG/10ML (5MG/ML)

100MG/20ML (5MG/ML)

A078803

A078803

A200979

A091358

A091358

A200979

A090849

A090849

A090849

A090849

N022160

N022160

001

002

001

001

002

002

001

001

002

002

001

002

Aug 08, 2012

Aug 08, 2012

Aug 08, 2012

Aug 07, 2012

Aug 07, 2012

Aug 08, 2012

Apr 28, 2011

Apr 28, 2011

Apr 28, 2011

Apr 28, 2011

Aug 07, 2009

Aug 07, 2009

Jul

Jul

Jul

Jul

Jul

Jul

Nov

Nov

Nov

Nov

Mar

Mar

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

DISC

DISC

DISC

DISC

CRLD

CRLD

OXAPROZIN

TABLET; ORAL OXAPROZIN @ MYLAN PHARMS INC 600MG A075847 001 Feb 28, 2001 Oct DISC

OXCARBAZEPINE

SUSPENSION; ORAL OXCARBAZEPINE

AB

AB

AMNEAL PHARMS 300MG/5ML

ROXANE 300MG/5ML

TABLET, EXTENDED RELEASE; ORAL OXTELLAR XR

A202961

A201193

001

001

Sep 17, 2012

Oct 03, 2012

Aug

Sep

NEWA

NEWA

+

SUPERNUS PHARMS 150MG

300MG

600MG

N202810

N202810

N202810

001

002

003

Oct 19, 2012

Oct 19, 2012

Oct 19, 2012

Oct

Oct

Oct

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 102: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-93

OXICONAZOLE NITRATE

CREAM; TOPICAL OXISTAT

+ FOUGERA PHARMS EQ 1% BASE N019828 001 Dec 30, 1988 Jan CAHN

OXTRIPHYLLINE

TABLET, EXTENDED RELEASE; ORAL CHOLEDYL SA

+

+

WARNER CHILCOTT LLC 400MG

600MG

A087863

A086742

001

001

May 24, 1983 Jun

Jun

CAHN

CAHN

OXYBUTYNIN

GEL, METERED; TRANSDERMAL ANTUROL

>D>

>A>

+

+

+

+

ARROW INTL

WATSON LABS INC

3%

3%

3%

3%

N202513

N202513

N202513

N202513

001

001

001

001

Dec 07, 2011

Dec 07, 2011

Dec 07, 2011

Dec 07, 2011

Nov

Apr

Nov

Feb

CAHN

CAHN

CAHN

CAHN

OXYBUTYNIN CHLORIDE

TABLET; ORAL DITROPAN @ JANSSEN PHARMS

OXYBUTYNIN CHLORIDE

5MG N017577 001 Mar DISC

AB + VINTAGE PHARMS 5MG

TABLET, EXTENDED RELEASE; ORAL OXYBUTYNIN CHLORIDE

A075079 001 Oct 31, 1997 Mar CRLD

AB MYLAN PHARMS INC 15MG A076644 002 May 10, 2007 Mar NEWA

OXYCODONE HYDROCHLORIDE

CAPSULE; ORAL OXYCODONE HYDROCHLORIDE

AB

AB

COASTAL PHARMS

+ LEHIGH VALLEY

SOLUTION; ORAL OXYCODONE HYDROCHLORIDE

5MG

5MG

A203107

N200534

001

001

Jul 26, 2012

Oct 20, 2010

Jul

Jul

NEWA

CFTG

AA

AA

+ LEHIGH VALLEY

+ VISTAPHARM

TABLET; ORAL OXYCODONE HYDROCHLORIDE

100MG/5ML

5MG/5ML

100MG/5ML

N200535

N201194

A202537

001

001

001

Oct 20, 2010

Jan 12, 2012

Jul 30, 2012

Jul

Jan

Jul

CFTG

NEWA

NEWA

>A>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AUROLIFE PHARMA LLC

MALLINCKRODT INC

SUN PHARM INDS INC

ROXICODONE

5MG

15MG

30MG

5MG

10MG

20MG

A202160

A202160

A202160

A076758

A090659

A090659

001

002

003

003

005

004

Nov 19, 2012

Nov 19, 2012

Nov 19, 2012

Mar 19, 2007

Nov 06, 2012

Nov 06, 2012

Nov

Nov

Nov

Apr

Nov

Nov

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB

AB

AB

+

MALLINCKRODT INC 5MG

15MG

30MG

N021011

N021011

N021011

003

001

002

May 15, 2009

Aug 31, 2000

Aug 31, 2000

Oct

Oct

Oct

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 103: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-94

OXYMORPHONE HYDROCHLORIDE

>D>

>A>

>D>

>A>

TABLET, EXTENDED RELEASE; ORAL OPANA ER @ ENDO PHARMS 5MG

@ 7.5MG

7.5MG

@ 7.5MG

@ 10MG

@ 15MG

15MG

@ 15MG

@ 20MG

@ 30MG

+ 40MG

@ 40MG

OXYMORPHONE HYDROCHLORIDE IMPAX LABS 5MG

10MG

20MG

30MG

40MG

N021610

N201655

N201655

N201655

N021610

N201655

N201655

N201655

N021610

N021610

N201655

N021610

A079087

A079087

A079087

A079087

A079087

001

002

002

002

002

004

004

004

003

007

007

004

001

003

005

006

007

Jun 22, 2006

Dec 09, 2011

Dec 09, 2011

Dec 09, 2011

Jun 22, 2006

Dec 09, 2011

Dec 09, 2011

Dec 09, 2011

Jun 22, 2006

Feb 29, 2008

Dec 09, 2011

Jun 22, 2006

Jun 14, 2010

Jun 14, 2010

Jun 14, 2010

Jul 22, 2010

Jun 14, 2010

May

Nov

Nov

Oct

May

Nov

Nov

Oct

May

May

Aug

May

May

May

May

May

May

DISC

CMFD

CMFD

DISC

DISC

CMFD

CMFD

DISC

DISC

DISC

CRLD

DISC

CTEC

CTEC

CTEC

CTEC

CTEC

OXYTOCIN

INJECTABLE; INJECTION OXYTOCIN @ TEVA PARENTERAL

@

PITOCIN JHP PHARMS

10USP UNITS/ML (10USP UNITS/ML)

100USP UNITS/10ML (10USP UNITS/ML)

500USP UNITS/50ML (10USP UNITS/ML)

A077453

A077453

N018261

001

002

003

Jan 24, 2008

Jan 24, 2008

Sep 05, 2012

Jan

Mar

Aug

DISC

DISC

NEWA

PACLITAXEL

AP

INJECTABLE; INJECTION PACLITAXEL

TEVA PHARMS

TAXOL @ CORDEN PHARMA

6MG/ML

6MG/ML

A075184

N020262

001

001

Jan 25, 2002

Dec 29, 1992

Oct

Mar

CAHN

CAHN

PAMIDRONATE DISODIUM

INJECTABLE; INJECTION AREDIA @ NOVARTIS 30MG/VIAL N020036 001 Oct 31, 1991 Mar DISC

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

CAPSULE, DELAYED RELEASE; ORAL CREON

ABBOTT LABS 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS

+ 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS

PERTZYE DIGESTIVE CARE INC 30,250USP/UNITS;8,000USP/UNITS;28

,750USP/UNITS

N020725

N020725

N020725

N020725

N022175

004

001

002

003

001

Jul 12, 2011

Apr 30, 2009

Apr 30, 2009

Apr 30, 2009

May 17, 2012

Jun

Feb

Feb

Feb

May

NEWA

CAHN

CAHN

CAHN

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 104: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-95

CAPSULE, DELAYED RELEASE; ORAL PERTZYE

+ DIGESTIVE CARE INC

ULTRESA

60,500USP/UNITS;16,000USP/UNITS;57,500USP/UNITS

N022175 002 May 17, 2012 May NEWA

APTALIS PHARMA US 27,600USP UNITS;13,800USP UNITS;27,600USP UNITS

N022222 001 Mar 01, 2012 Mar NEWA

41,400USP UNITS;20,700USP UNITS;41,400USP UNITS

N022222 002 Mar 01, 2012 Mar NEWA

+ 46,000USP UNITS;23,000USP UNITS;46,000USP UNITS

N022222 003 Mar 01, 2012 Mar NEWA

ZENPEP APTALIS PHARMA US 16,000USP UNITS;3,000USP

UNITS;10,000USP UNITS N022210 005 Jun 15, 2011 Apr NEWA

109,000USP UNITS;20,000USP UNITS;68,000USP UNITS

N022210 004 Aug 27, 2009 Apr CRLD

+ 136,000USP UNITS;25,000USP UNITS;85,000USP UNITS

N022210 006 Jul 13, 2011 Apr NEWA

TABLET; ORAL VIOKACE

APTALIS PHARMA US 39,150USP UNITS;10,440USP UNITS;39,150USP UNITS

N022542 001 Mar 01, 2012 Mar NEWA

+ 78,300USP UNITS;20,880USP UNITS;78,300USP UNITS

N022542 002 Mar 01, 2012 Mar NEWA

PANTOPRAZOLE SODIUM

INJECTABLE; IV (INFUSION)PANTOPRAZOLE SODIUM

AP AKORN INC EQ 40MG BASE/VIAL A079197 001 Nov 08, 2012 Oct NEWA

PROTONIX IV AP + WYETH PHARMS INC EQ 40MG BASE/VIAL N020988 001 Mar 22, 2001 Oct CFTG

TABLET, DELAYED RELEASE; ORAL PANTOPRAZOLE SODIUM

AB

AB

AB

AB

AB

APOTEX INC

AUROBINDO PHARMA LTD

MACLEODS PHARMS LTD

EQ 20MG BASE

EQ 40MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 20MG BASE

A090807

A090807

A202038

A202038

A200821

001

002

001

002

001

May 02, 2012

May 02, 2012

Sep 28, 2012

Sep 28, 2012

Feb 16, 2012

Apr

Apr

Sep

Sep

Jan

NEWA

NEWA

NEWA

NEWA

NEWA

AB EQ 40MG BASE A200821 002 Feb 16, 2012 Jan NEWA

AB MYLAN PHARMS INC EQ 20MG BASE A090970 001 Jan 19, 2011 Sep CAHN

AB

AB RANBAXY LABS LTD

EQ 40MG BASE

EQ 20MG BASE

A090970

A200794

002

001

Jan 19, 2011

May 02, 2012

Sep

Apr

CAHN

NEWA

AB EQ 40MG BASE A200794 002 May 02, 2012 Apr NEWA

PAROXETINE HYDROCHLORIDE

TABLET; ORAL PAROXETINE HYDROCHLORIDE

AB ACTAVIS ELIZABETH EQ 10MG BASE A076968 001 Jun 21, 2010 Feb CMFD

AB EQ 20MG BASE A076968 002 Jun 21, 2010 Feb CMFD

AB EQ 30MG BASE A076968 003 Jun 21, 2010 Feb CMFD

AB EQ 40MG BASE A076968 004 Jun 21, 2010 Feb CMFD

AB MYLAN PHARMS INC EQ 10MG BASE A075716 001 Mar 08, 2004 Sep CAHN

AB EQ 20MG BASE A075716 002 Mar 08, 2004 Sep CAHN

AB EQ 30MG BASE A075716 003 Mar 08, 2004 Sep CAHN

AB

AB PROSAM LABS

EQ 40MG BASE

EQ 10MG BASE

A075716

A076968

004

001

Mar 08, 2004

Jun 21, 2010

Sep

Sep

CAHN

CAHN

AB EQ 20MG BASE A076968 002 Jun 21, 2010 Sep CAHN

AB EQ 30MG BASE A076968 003 Jun 21, 2010 Sep CAHN

AB EQ 40MG BASE A076968 004 Jun 21, 2010 Sep CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 105: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-96

PEGAPTANIB SODIUM

INJECTABLE; INTRAVITREAL MACUGEN

+ VALEANT PHARMS LLC EQ 0.3MG ACID/0.09ML N021756 001 Dec 17, 2004 May CAHN

AP

AP

PEGINESATIDE ACETATE

SOLUTION; INTRAVENOUS, SUBCUTANEOUS OMONTYS

+ AFFYMAX EQ 10MG BASE/ML (EQ 10MG BASE/ML)

+ EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

OMONTYS PRESERVATIVE FREE + AFFYMAX EQ 1MG BASE/0.5ML (EQ 1MG

BASE/0.5ML)+ EQ 2MG BASE/0.5ML (EQ 2MG

BASE/0.5ML)+ EQ 3MG BASE/0.5ML (EQ 3MG

BASE/0.5ML) + EQ 4MG BASE/0.5ML (EQ 4MG

BASE/0.5ML) + EQ 5MG BASE/0.5ML (EQ 5MG

BASE/0.5ML)+ EQ 6MG BASE/0.5ML (EQ 6MG

BASE/0.5ML)

PENICILLIN G POTASSIUM

INJECTABLE; INJECTION PENICILLIN G POTASSIUM

IBI 5,000,000 UNITS/VIAL

20,000,000 UNITS/VIAL

N202799

N202799

N202799

N202799

N202799

N202799

N202799

N202799

A065448

A065448

007

008

001

002

003

004

005

006

001

002

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Aug 18, 2009

Aug 18, 2009

Mar

Mar

Mar

Mar

Mar

Mar

Mar

Mar

Sep

Sep

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CAHN

CAHN

PENTOBARBITAL SODIUM

INJECTABLE; INJECTION NEMBUTAL SODIUM

+ OAK PHARMS 50MG/ML A083246 001 Feb CAHN

PERAMPANEL

TABLET; ORAL FYCOMPA

EISAI INC

+

2MG

4MG

6MG

8MG

10MG

12MG

N202834

N202834

N202834

N202834

N202834

N202834

001

002

003

004

005

006

Oct 20, 2012

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Oct

Oct

Oct

Oct

Oct

Oct

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB

AB

AB

PERINDOPRIL ERBUMINE

TABLET; ORAL ACEON

XOMA

+

2MG

4MG

8MG

N020184

N020184

N020184

001

002

003

Dec 30, 1993

Dec 30, 1993

Dec 30, 1993

Jan

Jan

Jan

CAHN

CAHN

CAHN

AB

PERMETHRIN

CREAM; TOPICAL ELIMITE

+ RENAISSANCE PHARMA 5% N019855 001 Aug 25, 1989 May CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 106: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-97

PHENOXYBENZAMINE HYDROCHLORIDE

CAPSULE; ORAL DIBENZYLINE

AB + WELLSPRING PHARM 10MG N008708 001 Jun CFTG

PHENOXYBENZAMINE HYDROCHLORIDE AB ROXANE 10MG A201050 001 Jul 16, 2012 Jun NEWA

PHENTERMINE HYDROCHLORIDE

CAPSULE; ORAL PHENTERMINE HYDROCHLORIDE

AA

AA

AA

ELITE LABS 15MG

30MG

LANNETT 15MG

@ MIKAH PHARMA 15MG

@ 30MG

@ 30MG

@ 37.5MG

TABLET; ORAL PHENTERMINE HYDROCHLORIDE

A202248

A202248

A087022

A040460

A040227

A040448

A040228

001

002

002

001

001

001

001

Sep 28, 2012

Sep 28, 2012

Jan 20, 2012

Jan 14, 2003

Jun 18, 1997

Jan 22, 2003

Jun 19, 1997

Sep

Sep

Feb

Jul

Jul

Jul

Jul

NEWA

NEWA

NEWA

CAHN

CAHN

CAHN

CAHN

AA

@ ACTAVIS ELIZABETH 37.5MG

@ MIKAH PHARMA 37.5MG

MIRROR PHARMS 37.5MG

@ SANDOZ INC 30MG

TABLET, ORALLY DISINTEGRATING; ORAL SUPRENZA

A040276

A040190

A091451

A088605

001

001

001

001

Nov 25, 1998

May 30, 1997

Sep 21, 2012

Sep 28, 1987

Oct

Jul

Sep

Feb

DISC

CAHN

NEWA

DISC

+

CITIUS PHARMS 30MG

37.5MG

37.5MG

N202088

N202088

N202088

002

003

003

Jun 13, 2011

Mar 27, 2012

Mar 27, 2012

Apr

Apr

Mar

CRLD

CRLD

NEWA

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

CAPSULE, EXTENDED RELEASE; ORAL QSYMIA

VIVUS EQ 3.75MG BASE;23MG

EQ 7.5MG BASE;46MG

EQ 11.25MG BASE;69MG

+ EQ 15MG BASE;92MG

N022580

N022580

N022580

N022580

001

002

003

004

Jul 17, 2012

Jul 17, 2012

Jul 17, 2012

Jul 17, 2012

Jul

Jul

Jul

Jul

NEWA

NEWA

NEWA

NEWA

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL PHENTERMINE RESIN COMPLEX

+

+

LANNETT HOLDINGS INC EQ 15MG BASE

EQ 30MG BASE

A040872

A040872

001

002

Jul 28, 2011

Jul 28, 2011

Jan

Jan

CRLD

CRLD

PHENYTOIN SODIUM

INJECTABLE; INJECTION PHENYTOIN SODIUM

AP + HIKMA MAPLE 50MG/ML A084307 001 Jun CAHN

PHYTONADIONE

INJECTABLE; INJECTION PHYTONADIONE

BP + INTL MEDICATION

TABLET; ORAL MEPHYTON

1MG/0.5ML A083722 001 Feb CRLD

+ VALEANT PHARMS 5MG N010104 003 Jun CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 107: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-98

PIMECROLIMUS

CREAM; TOPICAL

ELIDEL + VALEANT BERMUDA 1% N021302 001 Dec 13, 2001 Oct CAHN

PINDOLOL

TABLET; ORAL PINDOLOL @ MYLAN PHARMS INC 5MG A074013 001 Sep 24, 1992 May CAHN

@ 10MG A074018 001 Sep 24, 1992 May CAHN

PIOGLITAZONE HYDROCHLORIDE

TABLET; ORAL ACTOS

AB TAKEDA PHARMS USA EQ 15MG BASE N021073 001 Jul 15, 1999 Aug CFTG

EQ 15MG BASE N021073 001 Jul 15, 1999 Mar CAHN

AB EQ 30MG BASE N021073 002 Jul 15, 1999 Aug CFTG

EQ 30MG BASE N021073 002 Jul 15, 1999 Mar CAHN

AB + EQ 45MG BASE N021073 003 Jul 15, 1999 Aug CFTG

+ EQ 45MG BASE N021073 003 Jul 15, 1999 Mar CAHN

PIOGLITAZONE HYDROCHLORIDE AB MYLAN PHARMS INC EQ 15MG BASE A076801 001 Aug 17, 2012 Aug NEWA

AB EQ 30MG BASE A076801 002 Aug 17, 2012 Aug NEWA

AB EQ 45MG BASE A076801 003 Aug 17, 2012 Aug NEWA

AB WATSON LABS EQ 15MG BASE A076798 001 Oct 26, 2012 Oct NEWA

AB EQ 30MG BASE A076798 002 Oct 26, 2012 Oct NEWA

AB EQ 45MG BASE A076798 003 Oct 26, 2012 Oct NEWA

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

FOR SOLUTION; ORAL CLENZ-LYTE @ PADDOCK LLC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5 A090769 001 Jun 07, 2010 Sep DISC

.86GM/BOT;22.74GM/BOT

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

FOR SOLUTION; ORAL POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES @ PADDOCK LLC 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5 A090712 001 Feb 25, 2010 Sep DISC

.84GM/BOT;22.72GM/BOT

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE; ORAL K+10 @ FUTURE PAK 10MEQ A070999 001 Oct 22, 1987 Mar DISC

KAON CL-10 @ SAVAGE LABS 10MEQ N017046 002 Mar DISC

KLOR-CON M20 AB + UPSHER SMITH LABS 20MEQ A074726 001 Nov 20, 1998 Mar CRLD

KLOTRIX @ APOTHECON 10MEQ N017850 001 Mar DISC

POTASSIUM CHLORIDE @ NESHER PHARMS 20MEQ A076044 001 Apr 05, 2002 Mar DISC

@ SCHERING 10MEQ N019439 002 Jun 13, 1986 Mar DISC

@ 20MEQ N019439 001 Jun 13, 1986 Mar DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 108: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-99

POTASSIUM CITRATE

FOR SOLUTION; ORAL POTASSIUM CITRATE @ NOVA K

@

10MEQ/PACKET

20MEQ/PACKET

002 N019647

001 N019647

FebOct 13, 1988

FebOct 13, 1988

CAHN

CAHN

PRAMIPEXOLE DIHYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

TABLET; ORAL PRAMIPEXOLE DIHYDROCHLORIDE

APOTEX INC 0.125MG

0.25MG

0.5MG

0.75MG

1MG

1.5MG

AUROBINDO PHARMA LTD 0.125MG

0.25MG

0.5MG

0.75MG

1MG

1.5MG

MACLEODS PHARMS LTD 0.125MG

0.25MG

0.5MG

1MG

1.5MG

001 A090151

002 A090151

003 A090151

006 A090151

004 A090151

005 A090151

001 A202633

002 A202633

003 A202633

004 A202633

005 A202633

006 A202633

001 A202164

002 A202164

003 A202164

004 A202164

005 A202164

AprApr 30, 2012

AprApr 30, 2012

AprApr 30, 2012

AprApr 30, 2012

AprApr 30, 2012

AprApr 30, 2012

OctOct 26, 2012

OctOct 26, 2012

OctOct 26, 2012

OctOct 26, 2012

OctOct 26, 2012

OctOct 26, 2012

SepSep 20, 2012

SepSep 20, 2012

SepSep 20, 2012

SepSep 20, 2012

SepSep 20, 2012

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

PRAVASTATIN SODIUM

AB

AB

AB

AB

TABLET; ORAL PRAVASTATIN SODIUM

MYLAN PHARMS INC

@ PLIVA HRVATSKA DOO

@

@

@

@ RANBAXY LABS LTD

@

@

@

10MG

20MG

40MG

80MG

10MG

20MG

30MG

40MG

10MG

20MG

40MG

80MG

001 A079187

002 A079187

003 A079187

004 A079187

001 A077730

002 A077730

003 A077730

005 A077730

001 A076445

002 A076445

003 A076445

004 A076445

OctMay 27, 2010

OctMay 27, 2010

OctMay 27, 2010

OctMay 27, 2010

JunNov 21, 2006

JunNov 21, 2006

JunNov 21, 2006

JunNov 21, 2006

AprApr 23, 2007

AprApr 23, 2007

AprApr 23, 2007

AprApr 23, 2007

CAHN

CAHN

CAHN

CAHN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PRAZOSIN HYDROCHLORIDE

>D>

>D>

>A>

>A>

AB

AB

AB

AB

CAPSULE; ORAL PRAZOSIN HYDROCHLORIDE

IVAX SUB TEVA PHARMS

TEVA PHARMS

EQ 2MG BASE

EQ 5MG BASE

EQ 2MG BASE

EQ 5MG BASE

001 A071995

001 A071745

001 A071995

001 A071745

NovSep 12, 1988

NovSep 12, 1988

NovSep 12, 1988

NovSep 12, 1988

CAHN

CAHN

CAHN

CAHN

PREDNICARBATE

AB

CREAM; TOPICAL PREDNICARBATE

FOUGERA PHARMS 0.1% 001 A077287 JanSep 19, 2006 CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 109: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-100

OINTMENT; TOPICAL PREDNICARBATE

AB FOUGERA PHARMS 0.1% A077236 001 Mar 09, 2007 Jan CAHN

PREDNISOLONE

SYRUP; ORAL PREDNISOLONE

AA + HI TECH PHARMA CO

@ NESHER PHARMS

@

15MG/5ML

5MG/5ML

15MG/5ML

A040401

A040423

A040364

001

001

001

Feb 27, 2003

Oct 22, 2001

Apr 10, 2002

Jul

Jun

Jun

CRLD

DISC

DISC

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION; ORAL PEDIAPRED

AA + SETON PHARM EQ 5MG BASE/5ML

PREDNISOLONE SODIUM PHOSPHATE

N019157 001 May 28, 1986 Sep CAHN

+ MISSION PHARMA

@ NESHER PHARMS

EQ 25MG BASE/5ML

EQ 5MG BASE/5ML

A091396

A076982

001

001

Sep 13, 2010

May 24, 2005

Jul

Jun

CAHN

DISC

PREDNISONE

TABLET; ORAL PREDNISONE

AB WEST WARD PHARM CORP 50MG A088465 001 Jun 01, 1984 Oct CMFD

TABLET, DELAYED RELEASE; ORAL RAYOS

+

HORIZON PHARMA 1MG

2MG

5MG

N202020

N202020

N202020

001

002

003

Jul 26, 2012

Jul 26, 2012

Jul 26, 2012

Jul

Jul

Jul

NEWA

NEWA

NEWA

PREGABALIN

CAPSULE; ORAL LYRICA

AB

AB

AB

AB

AB

AB

AB

AB +

+

PF PRISM

PREGABALIN

25MG

25MG

50MG

50MG

75MG

75MG

100MG

100MG

150MG

150MG

200MG

200MG

225MG

225MG

300MG

300MG

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

N021446

001

001

002

002

003

003

004

004

005

005

006

006

007

007

008

008

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Dec 30, 2004

Jun

Jan

Jun

Jan

Jun

Jan

Oct

Jan

Jun

Jan

Jun

Jan

Jun

Jan

Jun

Jan

CFTG

CAHN

CFTG

CAHN

CFTG

CAHN

CFTG

CAHN

CFTG

CAHN

CFTG

CAHN

CFTG

CAHN

CFTG

CAHN

AB

AB

AB

AB

AB

AB

AB

LUPIN LTD 25MG

50MG

75MG

100MG

150MG

200MG

225MG

A091040

A091040

A091040

A091040

A091040

A091040

A091040

001

002

003

004

005

006

007

Jul 03, 2012

Jul 03, 2012

Jul 03, 2012

Jul 03, 2012

Jul 03, 2012

Jul 03, 2012

Jul 03, 2012

Jun

Jun

Jun

Jun

Jun

Jun

Jun

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 110: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-101

CAPSULE; ORAL PREGABALIN

AB LUPIN LTD 300MG A091040 008 Jul 03, 2012 Jun NEWA

AB TEVA PHARMS 25MG A091219 001 Jul 03, 2012 Jun NEWA

AB 50MG A091219 002 Jul 03, 2012 Jun NEWA

AB 75MG A091224 001 Jul 03, 2012 Jun NEWA

AB 100MG A091224 002 Jul 03, 2012 Jun NEWA

AB 150MG A091224 003 Jul 03, 2012 Jun NEWA

AB 200MG A091224 004 Jul 03, 2012 Jun NEWA

AB 225MG A091224 005 Jul 03, 2012 Jun NEWA

AB 300MG A091224 006 Jul 03, 2012 Jun NEWA

AB WATSON LABS INC 25MG A091221 001 Jul 03, 2012 Jun NEWA

AB 50MG A091221 002 Jul 03, 2012 Jun NEWA

AB 75MG A091221 003 Jul 03, 2012 Jun NEWA

AB 100MG A091221 004 Jul 03, 2012 Jun NEWA

AB 150MG A091221 005 Jul 03, 2012 Jun NEWA

AB 200MG A091221 006 Jul 03, 2012 Jun NEWA

AB 225MG A091221 007 Jul 03, 2012 Jun NEWA

AB 300MG A091221 008 Jul 03, 2012 Jun NEWA

SOLUTION; ORAL LYRICA

+ PF PRISM 20MG/ML N022488 001 Jan 04, 2010 Jan CAHN

PRILOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION CITANEST PLAIN DENTAL @ DENTSPLY PHARM 4% N021382 001 May DISC

PRILOCAINE HYDROCHLORIDE + SEPTODONT INC 4% A079235 001 Sep 29, 2010 May CRLD

PROCAINAMIDE HYDROCHLORIDE

INJECTABLE; INJECTION PROCAINAMIDE HYDROCHLORIDE @ HIKMA MAPLE 100MG/ML A089029 001 Apr 17, 1986 Jun CAHN

@ 500MG/ML A089030 001 Apr 17, 1986 Jun CAHN

PROCHLORPERAZINE EDISYLATE

INJECTABLE; INJECTION PROCHLORPERAZINE EDISYLATE

AP +

@ HIKMA MAPLE EQ 5MG BASE/ML

EQ 5MG BASE/ML

A089523

A089903

001

001

May 03, 1988

Aug 29, 1989

Jun

Jun

CAHN

CAHN

PROGESTERONE

CAPSULE; ORAL PROGESTERONE

AB SOFGEN PHARMS 100MG A200456 001 Sep 28, 2012 Sep NEWA

AB 200MG A200456 002 Sep 28, 2012 Sep NEWA

AB TEVA PHARMS 100MG A202121 001 Feb 29, 2012 Feb NEWA

AB 200MG A202121 002 Feb 29, 2012 Feb NEWA

PROMETRIUM AB ABBOTT LABS 100MG N019781 001 May 14, 1998 Feb CFTG

AB + 200MG N019781 002 Oct 15, 1999 Feb CFTG

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 111: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-102

PROMETHAZINE HYDROCHLORIDE

INJECTABLE; INJECTION PROMETHAZINE HYDROCHLORIDE

AP

AP

HIKMA MAPLE 25MG/ML

50MG/ML

SUPPOSITORY; RECTAL PROMETHAZINE HYDROCHLORIDE

A083312

A083312

001

002

Oct

Oct

CAHN

CAHN

AB

AB

WATSON LABS INC 12.5MG

25MG

SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE

A040479

A040479

001

002

Jun 24, 2003

Jun 24, 2003

Oct

Oct

CAHN

CAHN

AA TRIS PHARMA INC 6.25MG/5ML A091675 001 Jun 28, 2012 Jun NEWA

PROPAFENONE HYDROCHLORIDE

TABLET; ORAL PROPAFENONE HYDROCHLORIDE @ NESHER PHARMS

@

@

150MG

225MG

300MG

A076193

A076193

A076193

001

002

003

Feb 07, 2002

Feb 07, 2002

Feb 07, 2002

Jun

Jun

Jun

DISC

DISC

DISC

PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL PROPRANOLOL HYDROCHLORIDE

AB

AB

AB

AB

APTALIS PHARMATECH 60MG

80MG

120MG

160MG

A078703

A078703

A078703

A078703

001

002

003

004

Jul 15, 2011

Jul 15, 2011

Jul 15, 2011

Jul 15, 2011

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

PROTAMINE SULFATE

INJECTABLE; INJECTION PROTAMINE SULFATE @ HIKMA MAPLE

@

10MG/ML

10MG/ML

A089474

A089475

001

001

Nov 05, 1986

Nov 05, 1986

Oct

Oct

CAHN

CAHN

PROTRIPTYLINE HYDROCHLORIDE

TABLET; ORAL PROTRIPTYLINE HYDROCHLORIDE

>A>

>A>

AB

AB

EPIC PHARMA LLC

VIVACTIL

5MG

10MG

A202220

A202220

001

002

Nov 19, 2012

Nov 19, 2012

Nov

Nov

NEWA

NEWA

@ TEVA WOMENS R AND D

@

5MG

10MG

N016012

N016012

001

002

Jul

Jul

CAHN

CAHN

PYRIDOSTIGMINE BROMIDE

TABLET; ORAL MESTINON

AB + VALEANT PHARMS LLC 60MG N009829 002 Jun CAHN

TABLET, EXTENDED RELEASE; ORAL MESTINON

+ VALEANT PHARMS LLC 180MG N011665 001 Jun CAHN

QUETIAPINE FUMARATE

AB

TABLET; ORAL QUETIAPINE FUMARATE

ACCORD HLTHCARE INC EQ 25MG BASE A202152 001 Mar 27, 2012 Mar NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 112: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-103

TABLET; ORAL QUETIAPINE FUMARATE

AB ACCORD HLTHCARE INC EQ 50MG BASE A202152 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A202152 003 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A202152 004 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A202152 005 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A202152 006 Mar 27, 2012 Mar NEWA

AB APOTEX INC EQ 25MG BASE A090960 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A090960 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A090960 003 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A090960 004 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A090960 005 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A090960 006 Mar 27, 2012 Mar NEWA

AB AUROBINDO PHARMA LTD EQ 25MG BASE A091388 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A091388 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A091388 003 Mar 27, 2012 Mar NEWA

AB EQ 150MG BASE A091388 004 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A091388 005 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A091388 006 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A091388 007 Mar 27, 2012 Mar NEWA

AB DR REDDYS LABS LTD EQ 25MG BASE A077380 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A077380 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A077380 003 Mar 27, 2012 Mar NEWA

AB EQ 150MG BASE A077380 004 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A077380 005 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A077380 006 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A077380 007 Mar 27, 2012 Mar NEWA

AB LUPIN LTD EQ 25MG BASE A201109 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A201109 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A201109 003 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A201109 004 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A201109 005 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A201109 006 Mar 27, 2012 Mar NEWA

AB MYLAN PHARMS INC EQ 25MG BASE A090323 001 Mar 27, 2012 Mar NEWA

AB ROXANE EQ 25MG BASE A090120 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A090749 001 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A090749 002 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A090749 003 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A090749 004 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A090749 005 Mar 27, 2012 Mar NEWA

AB SUN PHARMA GLOBAL EQ 25MG BASE A201190 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A201190 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A201190 003 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A201190 004 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A201190 005 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A201190 006 Mar 27, 2012 Mar NEWA

AB TEVA PHARMS EQ 25MG BASE A077745 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A077745 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A077745 003 Mar 27, 2012 Mar NEWA

AB EQ 150MG BASE A077745 004 Mar 27, 2012 Mar NEWA

AB EQ 200MG BASE A077745 005 Mar 27, 2012 Mar NEWA

AB EQ 300MG BASE A077745 006 Mar 27, 2012 Mar NEWA

AB EQ 400MG BASE A077745 007 Mar 27, 2012 Mar NEWA

AB TORRENT PHARMS LTD EQ 25MG BASE A200363 001 Mar 27, 2012 Mar NEWA

AB EQ 50MG BASE A200363 002 Mar 27, 2012 Mar NEWA

AB EQ 100MG BASE A200363 003 Mar 27, 2012 Mar NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 113: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-104

AB

AB

AB

AB

AB

AB

AB

AB

AB

TABLET; ORAL QUETIAPINE FUMARATE

TORRENT PHARMS LTD

SEROQUEL + ASTRAZENECA

+

EQ 200MG BASE

EQ 300MG BASE

EQ 400MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 200MG BASE

EQ 300MG BASE

EQ 400MG BASE

A200363

A200363

A200363

N020639

N020639

N020639

N020639

N020639

N020639

004

005

006

001

007

002

003

005

006

Mar 27, 2012

Mar 27, 2012

Mar 27, 2012

Sep 26, 1997

Oct 04, 2005

Sep 26, 1997

Sep 26, 1997

Jul 26, 2000

Oct 04, 2005

Mar

Mar

Mar

Mar

Mar

Mar

Mar

Mar

Mar

NEWA

NEWA

NEWA

CFTG

CFTG

CFTG

CFTG

CFTG

CFTG

QUINAPRIL HYDROCHLORIDE

TABLET; ORAL QUINAPRIL HYDROCHLORIDE @ SANDOZ

@

@

@

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

A076803

A076803

A076803

A076803

001

002

003

004

Mar 02, 2005

Mar 02, 2005

Mar 02, 2005

Mar 02, 2005

Aug

Aug

Aug

Aug

DISC

DISC

DISC

DISC

>D>

>A>

AB

AB

AB

AB

QUININE SULFATE

CAPSULE; ORAL QUALAQUIN

+ AR HOLDING CO INC

+

+ MUTUAL PHARM CO INC

QUININE SULFATE TEVA PHARMS

324MG

324MG

324MG

324MG

N021799

N021799

N021799

A091661

001

001

001

001

Aug 12, 2005

Aug 12, 2005

Aug 12, 2005

Sep 28, 2012

Nov

Sep

Nov

Sep

CAHN

CFTG

CAHN

NEWA

RAMELTEON

TABLET; ORAL ROZEREM

+ TAKEDA PHARMS USA 8MG N021782 001 Jul 22, 2005 Jul CAHN

RAMIPRIL

AB

AB

AB

AB

CAPSULE; ORAL RAMIPRIL @ RANBAXY LABS LTD

@

TABLET; ORAL ALTACE @ KING PFIZER

@

@

@

RAMIPRIL MYLAN PHARMS INC

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

A078849

A078849

N022021

N022021

N022021

N022021

A090650

A090650

A090650

A090650

001

002

001

002

003

004

001

002

003

004

Mar 06, 2009

Mar 06, 2009

Feb 27, 2007

Feb 27, 2007

Feb 27, 2007

Feb 27, 2007

Jun 30, 2011

Jun 30, 2011

Jun 30, 2011

Jun 30, 2011

Apr

Apr

Jan

Jan

Jan

Jan

Sep

Sep

Sep

Sep

DISC

DISC

DISC

DISC

DISC

DISC

CAHN

CAHN

CAHN

CAHN

RANITIDINE HYDROCHLORIDE

AP

INJECTABLE; INJECTION ZANTAC

+ COVIS PHARMA EQ 25MG BASE/ML N019090 001 Oct 19, 1984 Mar CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 114: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-105

INJECTABLE; INJECTION ZANTAC IN PLASTIC CONTAINER

+ COVIS PHARMA EQ 1MG BASE/ML

@ EQ 50MG BASE/100ML

SYRUP; ORAL RANITIDINE HYDROCHLORIDE

N019593

N019593

002

001

Sep 27, 1991

Dec 17, 1986

Mar

Mar

CAHN

CAHN

@ RANBAXY EQ 15MG BASE/ML A078448 001 Dec 13, 2007 Sep DISC

REGORAFENIB

TABLET; ORAL STIVARGA

+ BAYER HLTHCARE 40MG N203085 001 Sep 27, 2012 Sep NEWA

RIFAMPIN

CAPSULE; ORAL RIMACTANE

AB PROSAM LABS 300MG N050429 001 Feb CMFD

RILPIVIRINE HYDROCHLORIDE

TABLET; ORAL EDURANT

+ JANSSEN PRODS EQ 25MG BASE N202022 001 May 20, 2011 Feb CAHN

RISEDRONATE SODIUM

TABLET; ORAL ACTONEL

AB

AB

AB

WARNER CHILCOTT LLC 5MG

30MG

+ 35MG

@ 75MG

+ 150MG

TABLET, DELAYED RELEASE; ORAL ATELVIA

N020835

N020835

N020835

N020835

N020835

002

001

003

004

005

Apr 14, 2000

Mar 27, 1998

May 25, 2002

Apr 16, 2007

Apr 22, 2008

Jun

Jun

Jun

Jun

Jun

CAHN

CAHN

CAHN

CAHN

CAHN

+ WARNER CHILCOTT LLC 35MG N022560 001 Oct 08, 2010 Jun CAHN

RISPERIDONE

SOLUTION; ORAL RISPERIDONE

>A> AA TRIS PHARMA INC

TABLET; ORAL RISPERIDONE

1MG/ML A079059 001 Dec 12, 2012 Nov NEWA

AB

AB

AB

AB

AB

AB

PROSAM LABS 0.25MG

0.5MG

1MG

2MG

3MG

4MG

TABLET, ORALLY DISINTEGRATING; ORAL RISPERIDONE

A078071

A078071

A078071

A078071

A078071

A078071

001

002

003

004

005

006

Jun 17, 2009

Jun 17, 2009

Jun 17, 2009

Jun 17, 2009

Jun 17, 2009

Jun 17, 2009

Feb

Feb

Feb

Feb

Feb

Feb

CMFD

CMFD

CMFD

CMFD

CMFD

CMFD

AB

AB

AB

TEVA 0.5MG

1MG

2MG

A076908

A076908

A076908

001

002

003

Mar 12, 2012

Mar 12, 2012

Mar 12, 2012

Feb

Feb

Feb

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 115: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-106

RIVAROXABAN

TABLET; ORAL XARELTO

>A>

>A> +

JANSSEN PHARMS 15MG

20MG

N022406

N022406

002

003

Nov 04, 2011

Nov 04, 2011

Nov

Nov

CMS1

CMS1

RIVASTIGMINE

FILM, EXTENDED RELEASE; TRANSDERMAL EXELON

NOVARTIS 13.3MG/24HR N022083 005 Aug 31, 2012 Aug NEWA

RIVASTIGMINE TARTRATE

CAPSULE; ORAL RIVASTIGMINE TARTRATE

AB

AB

AB

AB

ALEMBIC PHARMS LTD EQ 1.5MG BASE

EQ 3MG BASE

EQ 4.5MG BASE

EQ 6MG BASE

A091689

A091689

A091689

A091689

001

002

003

004

Jun 12, 2012

Jun 12, 2012

Jun 12, 2012

Jun 12, 2012

May

May

May

May

NEWA

NEWA

NEWA

NEWA

ROCURONIUM BROMIDE

INJECTABLE; INJECTION ROCURONIUM BROMIDE

AP

AP

AP

AP

TAMARANG

TEVA PHARMS

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

A091115

A091115

A078717

A078717

001

002

001

002

Aug 27, 2012

Aug 27, 2012

Nov 26, 2008

Nov 26, 2008

Aug

Aug

Sep

Sep

NEWA

NEWA

CAHN

CAHN

ROPINIROLE HYDROCHLORIDE

TABLET; ORAL ROPINIROLE HYDROCHLORIDE

>A>

>A>

>A>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

APOTEX

ORCHID HLTHCARE

EQ 0.25MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 3MG BASE

EQ 4MG BASE

EQ 5MG BASE

EQ 0.25MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 3MG BASE

EQ 4MG BASE

EQ 5MG BASE

A079165

A079165

A079165

A079165

A079165

A079165

A079165

A079229

A079229

A079229

A079229

A079229

A079229

A079229

001

002

003

004

005

006

007

001

002

003

004

005

006

007

Feb 07, 2012

Feb 07, 2012

Feb 07, 2012

Feb 07, 2012

Feb 07, 2012

Feb 07, 2012

Feb 07, 2012

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Jan

Jan

Jan

Jan

Jan

Jan

Jan

Nov

Nov

Nov

Nov

Nov

Nov

Nov

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AB

AB

AB

AB

AB

TABLET, EXTENDED RELEASE; ORAL REQUIP XL

+ SMITHKLINE BEECHAM EQ 2MG BASE

EQ 4MG BASE

EQ 6MG BASE

EQ 8MG BASE

EQ 12MG BASE

ROPINIROLE HYDROCHLORIDE

N022008

N022008

N022008

N022008

N022008

001

003

006

004

005

Jun 13, 2008

Jun 13, 2008

Apr 10, 2009

Jun 13, 2008

Oct 31, 2008

Apr

Apr

Apr

Apr

Apr

CFTG

CFTG

CFTG

CFTG

CFTG

AB

AB

AB

ACTAVIS EQ 2MG BASE

EQ 4MG BASE

EQ 6MG BASE

A090869

A090869

A090869

001

002

003

May 17, 2012

May 17, 2012

May 17, 2012

Apr

Apr

Apr

NEWA

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 116: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-107

TABLET, EXTENDED RELEASE; ORAL ROPINIROLE HYDROCHLORIDE

AB

AB

AB

AB

ACTAVIS

DR REDDYS LABS LTD

EQ 8MG BASE

EQ 12MG BASE

EQ 2MG BASE

EQ 4MG BASE

A090869

A090869

A201576

A201576

004

005

001

002

May 17, 2012

May 17, 2012

Jun 06, 2012

Jun 06, 2012

Apr

Apr

May

May

NEWA

NEWA

NEWA

NEWA

AB EQ 6MG BASE A201576 003 Jun 06, 2012 May NEWA

AB EQ 8MG BASE A201576 004 Jun 06, 2012 May NEWA

AB

AB MYLAN PHARMS INC

EQ 12MG BASE

EQ 2MG BASE

A201576

A200462

005

001

Jun 06, 2012

Oct 15, 2012

May

Oct

NEWA

NEWA

EQ 3MG BASE A200462 002 Oct 15, 2012 Oct NEWA

AB EQ 4MG BASE A200462 003 Oct 15, 2012 Oct NEWA

AB EQ 6MG BASE A200462 004 Oct 15, 2012 Oct NEWA

AB EQ 8MG BASE A200462 005 Oct 15, 2012 Oct NEWA

AB EQ 12MG BASE A200462 006 Oct 15, 2012 Oct NEWA

AB

AB

AB

AB

AB

SANDOZ INC EQ 2MG BASE

EQ 4MG BASE

EQ 6MG BASE

EQ 8MG BASE

EQ 12MG BASE

A201047

A201047

A201047

A201047

A201047

001

003

004

005

006

Jun 06, 2012

Jun 06, 2012

Jun 06, 2012

Jun 06, 2012

Jun 06, 2012

May

May

May

May

May

NEWA

NEWA

NEWA

NEWA

NEWA

AB WATSON LABS INC EQ 2MG BASE A200431 001 Jun 06, 2012 May NEWA

AB EQ 4MG BASE A200431 002 Jun 06, 2012 May NEWA

AB

AB

AB

AB

AB

WOCKHARDT LTD

EQ 6MG BASE

EQ 8MG BASE

EQ 12MG BASE

EQ 2MG BASE

EQ 4MG BASE

A200431

A200431

A200431

A091395

A091395

003

004

005

001

002

Jun 06, 2012

Jun 06, 2012

Jun 06, 2012

Aug 27, 2012

Aug 27, 2012

May

May

May

Aug

Aug

NEWA

NEWA

NEWA

NEWA

NEWA

AB EQ 6MG BASE A091395 003 Aug 27, 2012 Aug NEWA

AB EQ 8MG BASE A091395 004 Aug 27, 2012 Aug NEWA

AB EQ 12MG BASE A091395 005 Aug 27, 2012 Aug NEWA

ROTIGOTINE

FILM, EXTENDED RELEASE; TRANSDERMAL NEUPRO

UCB INC 1MG/24HR N021829 004 Apr 02, 2012 Apr NEWA

2MG/24HR N021829 001 May 09, 2007 Apr CMFD

3MG/24HR

4MG/24HR

N021829

N021829

005

002

Apr 02, 2012

May 09, 2007

Apr

Apr

NEWA

CMFD

6MG/24HR N021829 003 May 09, 2007 Apr CMFD

+ 8MG/24HR N021829 006 Apr 02, 2012 Apr NEWA

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

INJECTABLE; INJECTION QUADRAMET

+ JAZZ EUSA PHARMA 50mCi/ML N020570 001 Mar 28, 1997 Jul CAHN

SELEGILINE HYDROCHLORIDE

TABLET; ORAL SELEGILINE HYDROCHLORIDE @ VINTAGE PHARMS LLC 5MG A074565 001 Aug 02, 1996 Sep CAHN

SERTACONAZOLE NITRATE

CREAM; TOPICAL ERTACZO

+ VALEANT INTL 2% N021385 001 Dec 10, 2003 Jan CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 117: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-108

SERTRALINE HYDROCHLORIDE

CONCENTRATE; ORAL SERTRALINE HYDROCHLORIDE @ RANBAXY LABS LTD EQ 20MG BASE/ML A078053 001 Feb 05, 2007 Aug DISC

TABLET; ORAL SERTRALINE HYDROCHLORIDE @ MYLAN PHARMS INC EQ 25MG BASE A076540 001 Mar 20, 2007 Oct DISC

AB

@

EQ 25MG BASE

EQ 50MG BASE

A078626

A076540

001

002

Jan 31, 2008

Mar 20, 2007

Sep

Oct

CAHN

DISC

AB

@

EQ 50MG BASE

EQ 100MG BASE

A078626

A076540

002

003

Jan 31, 2008

Mar 20, 2007

Sep

Oct

CAHN

DISC

AB EQ 100MG BASE A078626 003 Jan 31, 2008 Sep CAHN

AB PROSAM LABS EQ 25MG BASE A078175 001 Jul 21, 2010 Feb CMFD

AB EQ 50MG BASE A078175 002 Jul 21, 2010 Feb CMFD

AB EQ 100MG BASE A078175 003 Jul 21, 2010 Feb CMFD

SILDENAFIL CITRATE

FOR SUSPENSION; ORAL REVATIO

+ PFIZER 10MG/ML N203109 001 Aug 30, 2012 Aug NEWA

TABLET; ORAL REVATIO

AB + PFIZER EQ 20MG BASE N021845 001 Jun 03, 2005 Oct CFTG

SILDENAFIL CITRATE AB APOTEX CORP EQ 20MG BASE A091379 001 Nov 06, 2012 Oct NEWA

AB DR REDDYS LABS LTD EQ 20MG BASE A202598 001 Nov 06, 2012 Oct NEWA

AB MYLAN PHARMS INC EQ 20MG BASE A201150 001 Nov 09, 2012 Oct NEWA

AB TORRENT PHARMS LTD EQ 20MG BASE A091479 001 Nov 06, 2012 Oct NEWA

AB WATSON LABS INC EQ 20MG BASE A202503 001 Nov 06, 2012 Oct NEWA

SILODOSIN

CAPSULE; ORAL RAPAFLO

+ WATSON LABS 4MG N022206 001 Oct 08, 2008 Oct CRLD

8MG N022206 002 Oct 08, 2008 Oct CRLD

SILVER SULFADIAZINE

CREAM; TOPICAL THERMAZENE

AB THEPHARMANETWORK LLC 1% N018810 001 Dec 23, 1985 Jun CAHN

SIMVASTATIN

TABLET; ORAL SIMVASTATIN

AB MYLAN PHARMS INC 5MG A090868 001 Jun 08, 2010 Sep CAHN

AB 10MG A090868 002 Jun 08, 2010 Sep CAHN

AB 20MG A090868 003 Jun 08, 2010 Sep CAHN

AB 40MG A090868 004 Jun 08, 2010 Sep CAHN

AB 80MG A090868 005 Jun 08, 2010 Sep CAHN

AB

AB

PROSAM LABS 5MG

10MG

A078735

A078735

001

002

Aug 30, 2010

Aug 30, 2010

Feb

Feb

CMFD

CMFD

AB 20MG A078735 003 Aug 30, 2010 Feb CMFD

AB 40MG A078735 004 Aug 30, 2010 Feb CMFD

AB 80MG A078735 005 Aug 30, 2010 Feb CMFD

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 118: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-109

SIMVASTATIN; SITAGLIPTIN PHOSPHATE

TABLET; ORAL JUVISYNC

MERCK SHARP DOHME 10MG;EQ 50MG BASE

20MG;EQ 50MG BASE

40MG;EQ 50MG BASE

N202343

N202343

N202343

004

005

006

Sep 18, 2012

Sep 18, 2012

Sep 18, 2012

Sep

Sep

Sep

NEWA

NEWA

NEWA

SITAGLIPTIN PHOSPHATE

TABLET; ORAL JANUVIA

+

MERCK SHARP DOHME EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

N021995

N021995

N021995

001

002

003

Oct 16, 2006

Oct 16, 2006

Oct 16, 2006

May

May

May

CAHN

CAHN

CAHN

SODIUM BICARBONATE; TARTARIC ACID

GRANULE, EFFERVESCENT; ORAL BAROS @ MALLINCKRODT INC 460MG/GM;420MG/GM N018509 001 Aug 07, 1985 Jan CAHN

SODIUM CHLORIDE

INJECTABLE; INJECTION SODIUM CHLORIDE 0.9%

AP HIKMA (MAPLE) 9MG/ML

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

A201850 001 Jan 20, 2012 Jan NEWA

MEDEFIL 9MG/ML N202832 001 Jan 06, 2012 Jan NEWA

SODIUM CHROMATE CR-51

INJECTABLE; INJECTION CHROMITOPE SODIUM @ BRACCO 200uCi/ML N013993 001 Jun DISC

SODIUM FERRIC GLUCONATE COMPLEX

INJECTABLE; INJECTION SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

AB HIKMA PHARMS 62.5MG/5ML A078215 001 Mar 31, 2011 May CAHN

SODIUM IODIDE I-123

CAPSULE; ORAL SODIUM IODIDE I 123 @ GE HEALTHCARE

SYNCOR PHARMS

SOLUTION; ORAL SODIUM IODIDE I 123

100uCi

400uCi

N017630

N018671

001

003 May 27, 1982

May

Oct

DISC

CMFD

@ GE HEALTHCARE 2mCi/ML N017630 002 Jul DISC

SODIUM IODIDE I-131

CAPSULE; ORAL SODIUM IODIDE I-131

JUBILANT DRAXIMAGE

@

SOLUTION; ORAL HICON

9-100mCi

2-200mCi

N021305

N021305

006

004

May 19, 2005

Nov 18, 2004

Feb

Jan

CAHN

DISC

@ JUBILANT DRAXIMAGE

@

@

1-500mCi/0.5ML

1-1000mCi/ML

1-250mCi/0.25ML

N021305

N021305

N021305

003

005

002

Jan 24, 2003

Apr 04, 2006

Jan 24, 2003

Feb

Feb

Feb

DISC

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 119: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-110

SOLUTION; ORAL HICON

+ JUBILANT DRAXIMAGE 250-1000mCi N021305 007 Dec 05, 2011 Jan NEWA

SODIUM NITRITE

SOLUTION; INTRAVENOUS SODIUM NITRITE

+ HOPE PHARMS 300MG/10ML (30MG/ML) N203922 001 Feb 14, 2012 Feb NEWA

SODIUM OXYBATE

SOLUTION; ORAL XYREM

+ JAZZ PHARMS 500MG/ML N021196 001 Jul 17, 2002 Jun CAHN

SODIUM POLYSTYRENE SULFONATE

POWDER; ORAL, RECTAL SODIUM POLYSTYRENE SULFONATE @ CITRUSPHRMA 454GM/BOT A040909 001 Dec 03, 2008 Jun DISC

SODIUM THIOSULFATE

SOLUTION; INTRAVENOUS SODIUM THIOSULFATE

+ HOPE PHARMS 12.5GM/50ML (250MG/ML) N203923 001 Feb 14, 2012 Feb NEWA

SOMATROPIN RECOMBINANT

INJECTABLE; INJECTION NORDITROPIN @ NOVO NORDISK INC

@

@

NORDITROPIN NORDIFLEX @ NOVO NORDISK INC

@

@

5MG/1.5ML

10MG/1.5ML

15MG/1.5ML

5MG/1.5ML

10MG/1.5ML

15MG/1.5ML

N021148

N021148

N021148

N021148

N021148

N021148

001

002

003

004

005

006

Jun 20, 2000

Jun 20, 2000

Jun 20, 2000

Oct 01, 2004

Oct 01, 2004

Oct 01, 2004

Jul

Jul

Jul

Sep

Sep

Sep

DISC

DISC

DISC

DISC

DISC

DISC

SOTALOL HYDROCHLORIDE

AB2

AB2

AB2

TABLET; ORAL SOTALOL HYDROCHLORIDE

EPIC PHARMA INC 80MG

120MG

160MG

A077070

A077070

A077070

001

002

003

Nov 04, 2005

Nov 04, 2005

Nov 04, 2005

Jun

Jun

Jun

CAHN

CAHN

CAHN

SPINOSAD

SUSPENSION; TOPICAL NATROBA

+ PARAPRO LLC 0.9% N022408 001 Jan 18, 2011 May CAHN

SUCCIMER

CAPSULE; ORAL CHEMET

+ LUNDBECK LLC 100MG N019998 002 Jan 30, 1991 Mar CAHN

SUFENTANIL CITRATE

AP

INJECTABLE; INJECTION SUFENTANIL CITRATE

HIKMA MAPLE EQ 0.05MG BASE/ML A074413 001 Dec 15, 1995 Oct CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 120: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-111

SULFACETAMIDE SODIUM

LOTION; TOPICAL SULFACETAMIDE SODIUM

AB FOUGERA PHARMS 10% A077015 001 Nov 17, 2006 Jan CAHN

SULFAMETHOXAZOLE; TRIMETHOPRIM

INJECTABLE; INJECTION SULFAMETHOXAZOLE AND TRIMETHOPRIM @ HIKMA MAPLE 80MG/ML;16MG/ML A070627 001 Dec 29, 1987 Oct CAHN

@ 80MG/ML;16MG/ML A070628 001 Dec 29, 1987 Oct CAHN

SUSPENSION; ORAL SULFATRIM @ STI PHARMA LLC 200MG/5ML;40MG/5ML N018615 002 Jan 07, 1983 Aug CAHN

SULFATRIM PEDIATRIC AB STI PHARMA LLC 200MG/5ML;40MG/5ML N018615 001 Jan 07, 1983 Aug CAHN

TABLET; ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH

>D> AB PLANTEX 400MG;80MG A070030 001 Jun 02, 1987 Nov CAHN

>A> AB TEVA PHARMS 400MG;80MG A070030 001 Jun 02, 1987 Nov CAHN

SULFANILAMIDE

CREAM; VAGINAL AVC

+ JAZZ PHARMS COMMERCL 15% N006530 003 Jan 27, 1987 Mar CAHN

+ JAZZ PHARMS II 15% N006530 003 Jan 27, 1987 Jul CAHN

+ JAZZ PHARMS III 15% N006530 003 Jan 27, 1987 Jun CAHN

>A> + MEDA PHARMS 15% N006530 003 Jan 27, 1987 Nov CAHN

>D> + MEDPOINTE 15% N006530 003 Jan 27, 1987 Nov CAHN

+ 15% N006530 003 Jan 27, 1987 Oct CAHN

SUPPOSITORY; VAGINAL AVC @ JAZZ PHARMS COMMERCL 1.05GM N006530 004 Jan 27, 1987 Mar CAHN

@ JAZZ PHARMS II 1.05GM N006530 004 Jan 27, 1987 Jul CAHN

@ JAZZ PHARMS III 1.05GM N006530 004 Jan 27, 1987 Jun CAHN

>A> @ MEDA PHARMS 1.05GM N006530 004 Jan 27, 1987 Nov CAHN

>D> @ MEDPOINTE 1.05GM N006530 004 Jan 27, 1987 Nov CAHN

@ 1.05GM N006530 004 Jan 27, 1987 Oct CAHN

SUMATRIPTAN SUCCINATE

INJECTABLE; SUBCUTANEOUS ALSUMA

BX MERIDIAN MEDCL

SUMATRIPTAN SUCCINATE

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022377 001 Jun 29, 2010 Jun CRLD

AP

AB

INJECTALIA

SUN PHARMA GLOBAL

SUMAVEL DOSEPRO

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

A090310

A090358

001

001

Aug 11, 2010

Jun 21, 2011

Mar

Oct

CAHN

CAHN

BX + ZOGENIX INC

TABLET; ORAL

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022239 001 Jul 15, 2009 Jun CTEC

SUMATRIPTAN SUCCINATE AB APOTEX INC EQ 25MG BASE A200263 001 Jun 19, 2012 Jun NEWA

AB EQ 50MG BASE A200263 002 Jun 19, 2012 Jun NEWA

AB EQ 100MG BASE A200263 003 Jun 19, 2012 Jun NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 121: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-112

TACROLIMUS

AB

AB

AB

AB

AB

AB

CAPSULE; ORAL TACROLIMUS

ACCORD HLTHCARE

PANACEA BIOTEC LTD

EQ 0.5MG BASE

EQ 1MG BASE

EQ 5MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 5MG BASE

A091195

A091195

A091195

A090802

A090802

A090802

001

002

003

001

002

003

Aug 31, 2011

Aug 31, 2011

Aug 31, 2011

Sep 28, 2012

Sep 28, 2012

Sep 28, 2012

Sep

Sep

Sep

Sep

Sep

Sep

CPOT

CPOT

CPOT

NEWA

NEWA

NEWA

TAFLUPROST

SOLUTION/DROPS; OPHTHALMICZIOPTAN

+ MERCK SHARP DOHME 0.0015% N202514 001 Feb 10, 2012 Feb NEWA

TALIGLUCERASE ALFA

POWDER; IV (INFUSION)ELELYSO

+ PFIZER 200 UNITS/VIAL N022458 001 May 01, 2012 May NEWA

TAMOXIFEN CITRATE

SOLUTION; ORAL SOLTAMOX

ONCOGENERIX PHARMS

TABLET; ORAL TAMOXIFEN CITRATE @ AEGIS PHARMS

@

EQ 10MG BASE/5ML

EQ 10MG BASE

EQ 20MG BASE

N021807

A076398

A076398

001

001

002

Oct 29, 2005

Mar 31, 2003

Mar 31, 2003

Aug

Jun

Jun

CMFD

DISC

DISC

TAPENTADOL HYDROCHLORIDE

SOLUTION; ORAL NUCYNTA

+ JANSSEN PHARMS EQ 20MG BASE/ML N203794 001 Oct 15, 2012 Oct NEWA

TAZAROTENE

AEROSOL, FOAM; TOPICAL FABIOR

+ STIEFEL LABS INC 0.1% N202428 001 May 11, 2012 May NEWA

TECHNETIUM TC-99M MEDRONATE

INJECTABLE; INJECTION DRAXIMAGE MDP-10 @ JUBILANT DRAXIMAGE

DRAXIMAGE MDP-25 + JUBILANT DRAXIMAGE

N/A

N/A

N018035

N018035

001

002 Feb 27, 2004

May

May

CAHN

CAHN

TEMAZEPAM

AB

AB

CAPSULE; ORAL TEMAZEPAM

NOVEL LABS INC 7.5MG

22.5MG

A071457

A071457

002

003

Jun 22, 2012

Jun 22, 2012

Jun

Jun

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 122: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-113

TEMOZOLOMIDE

AB

AB

AB

AB

AB

AB

CAPSULE; ORAL TEMODAR

MERCK SHARP DOHME

+

POWDER; INTRAVENOUS TEMODAR

+ MERCK SHARP DOHME

5MG

20MG

100MG

140MG

180MG

250MG

100MG/VIAL

N021029

N021029

N021029

N021029

N021029

N021029

N022277

001

002

003

005

006

004

001

Aug 11, 1999

Aug 11, 1999

Aug 11, 1999

Oct 19, 2006

Oct 19, 2006

Aug 11, 1999

Feb 27, 2009

Jun

Jun

Jun

Jun

Jun

Jun

Jun

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

TENOFOVIR DISOPROXIL FUMARATE

POWDER; ORAL VIREAD

+ GILEAD SCIENCES INC

TABLET; ORAL VIREAD

GILEAD SCIENCES INC

40MG/SCOOPFUL

150MG

200MG

250MG

N022577

N021356

N021356

N021356

001

002

003

004

Jan 18, 2012

Jan 18, 2012

Jan 18, 2012

Jan 18, 2012

Jan

Apr

Apr

Apr

NEWA

NEWA

NEWA

NEWA

TERAZOSIN HYDROCHLORIDE

CAPSULE; ORAL TERAZOSIN HYDROCHLORIDE @ RANBAXY LABS LTD

@

@

@

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

A076021

A076021

A076021

A076021

001

002

003

004

Aug 22, 2002

Aug 22, 2002

Aug 22, 2002

Aug 22, 2002

Apr

Apr

Apr

Apr

DISC

DISC

DISC

DISC

TERBUTALINE SULFATE

INJECTABLE; INJECTION TERBUTALINE SULFATE @ TEVA PARENTERAL 1MG/ML A076853 001 Jul 20, 2004 Jan DISC

TERCONAZOLE

AB

AB

CREAM; VAGINAL TERCONAZOLE

FOUGERA PHARMS

SUPPOSITORY; VAGINAL TERCONAZOLE

FOUGERA PHARMS

0.4%

80MG

A076712

A076850

001

001

Feb 18, 2005

Jul 12, 2006

Jan

Jan

CAHN

CAHN

TERIFLUNOMIDE

TABLET; ORAL AUBAGIO

SANOFI AVENTIS US

+

7MG

14MG

N202992

N202992

001

002

Sep 12, 2012

Sep 12, 2012

Sep

Sep

NEWA

NEWA

TESAMORELIN ACETATE

POWDER; SUBCUTANEOUS EGRIFTA @ EMD SERONO

+

EQ 1MG BASE/VIAL

EQ 1MG BASE/VIAL

N022505

N022505

001

001

Nov 10, 2010

Nov 10, 2010

Jun

May

DISC

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 123: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-114

POWDER; SUBCUTANEOUS

EGRIFTA + EMD SERONO EQ 2MG BASE/VIAL

TESTOSTERONE

GEL; TRANSDERMAL ANDROGEL

BX + ABBOTT LABS 1% (50MG/5GM PACKET)

1% (25MG/2.5GM PACKET)

ABBVIE 1.62% (20.25MG/1.25GM PACKET)

+ 1.62% (40.5MG/2.5GM PACKET)

TESTIM BX + AUXILIUM PHARMS 1% (50MG/5GM PACKET)

TESTOSTERONE TEVA PHARMS 25MG/2.5GM PACKET

50MG/5GM PACKET

GEL, METERED; TRANSDERMAL

ANDROGEL

+ ABBOTT LABS 1% (1.25GM/ACTUATION)

FORTESTA + ENDO PHARMS 10MG/0.5GM ACTUATION

PELLET; IMPLANTATION

TESTOPEL + ACTIENT PHARMS 75MG

SOLUTION, METERED; TRANSDERMAL

AXIRON

+ ELI LILLY AND CO 30MG/1.5ML ACTUATION

TESTOSTERONE CYPIONATE

INJECTABLE; INJECTION TESTOSTERONE CYPIONATE

AO HIKMA FARMACEUTICA 200MG/ML

AO MYLAN INSTITUTIONAL 200MG/ML

TESTOSTERONE ENANTHATE

INJECTABLE; INJECTION TESTOSTERONE ENANTHATE

AO HIKMA FARMACEUTICA 200MG/ML

AO MYLAN INSTITUTIONAL 200MG/ML

TETRABENAZINE

TABLET; ORAL

XENAZINE

VALEANT BERMUDA 12.5MG

+ 25MG

VALEANT PHARMS 12.5MG

+ 25MG

TETRAHYDROZOLINE HYDROCHLORIDE

SOLUTION; NASAL

TYZINE + FOUGERA PHARMS 0.05%

0.1%

SPRAY; NASAL

TYZINE + FOUGERA PHARMS 0.1%

N022505

N021015

N021015

N022309

N022309

N021454

N202763

N202763

N021015

N021463

A080911

N022504

A091244

A040652

A091120

A040647

N021894

N021894

N021894

N021894

A086576

A086576

A086576

002

002

001

002

003

001

001

002

003

001

001

001

001

001

001

001

001

002

001

002

002

001

003

JunNov 29, 2011 NEWA

FebFeb 28, 2000 CPOT

FebFeb 28, 2000 CPOT

SepSep 07, 2012

SepSep 07, 2012

NEWA

NEWA

FebOct 31, 2002 CPOT

FebFeb 14, 2012 NEWA

FebFeb 14, 2012 NEWA

JunSep 26, 2003 CPOT

SepDec 29, 2010 CPOT

May CAHN

SepNov 23, 2010 CPOT

AprMay 01, 2012 NEWA

FebDec 11, 2006 CAHN

SepSep 18, 2012 NEWA

FebOct 05, 2009 CAHN

OctAug 15, 2008

OctAug 15, 2008

CAHN

CAHN

AprAug 15, 2008 CAHN

AprAug 15, 2008 CAHN

Jan CAHN

Jan CAHN

Jan CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 124: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-115

THEOPHYLLINE

>A>

>A>

>A>

>A>

>D>

>D>

>D>

>D>

AA

AA

CAPSULE, EXTENDED RELEASE; ORAL THEO-24

ACTIENT PHARMS 100MG

200MG

300MG

+ 400MG

UCB INC 100MG

100MG

200MG

200MG

300MG

300MG

+ 400MG

+ 400MG

THEOPHYLLINE @ INWOOD LABS 100MG

@ 125MG

@ 200MG

@ 300MG

INJECTABLE; INJECTION THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER @ BAXTER HLTHCARE 4MG/ML

@ 40MG/100ML

@ 80MG/100ML

@ 160MG/100ML

@ 200MG/100ML

@ 320MG/100ML

@ 400MG/100ML

SOLUTION; ORAL THEOPHYLLINE

+ SILARX 80MG/15ML

TRIS PHARMA INC 80MG/15ML

TABLET; ORAL THEOLAIR

+ MEDICIS 125MG

+ 250MG

TABLET, EXTENDED RELEASE; ORAL THEOPHYLLINE @ INWOOD LABS 450MG

UNIPHYL @ RHODES PHARMS 400MG

@ 600MG

A087942

A087943

A087944

A081034

A087942

A087942

A087943

A087943

A087944

A087944

A081034

A081034

A040052

A040052

A040052

A040052

N018649

N018649

N018649

N018649

N018649

N018649

N018649

A091156

A091586

A086399

A086399

A040034

A087571

A040086

001

001

001

001

001

001

001

001

001

001

001

001

001

002

003

004

007

001

002

003

004

006

005

001

001

001

002

001

001

001

Aug 22, 1983

Aug 22, 1983

Aug 22, 1983

Feb 28, 1992

Aug 22, 1983

Aug 22, 1983

Aug 22, 1983

Aug 22, 1983

Aug 22, 1983

Aug 22, 1983

Feb 28, 1992

Feb 28, 1992

Feb 14, 1994

Feb 14, 1994

Feb 14, 1994

Feb 14, 1994

Jul 26, 1982

Jul 26, 1982

Jul 26, 1982

Jul 26, 1982

Jul 26, 1982

Nov 13, 1985

Jul 26, 1982

Apr 13, 2011

Jun 15, 2012

Apr 28, 1995

Sep 01, 1982

Apr 15, 1996

Nov

Nov

Nov

Nov

Nov

May

Nov

May

Nov

May

Nov

May

May

May

May

May

Mar

Mar

Mar

Mar

Mar

Mar

Mar

Jun

Jun

Jul

Jul

Oct

Sep

Sep

CAHN

CAHN

CAHN

CAHN

CAHN

CTEC

CAHN

CTEC

CAHN

CTEC

CAHN

CRLD

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

CTEC

NEWA

CAHN

CAHN

DISC

CAHN

CAHN

THIAMINE HYDROCHLORIDE

AP

INJECTABLE; INJECTION THIAMINE HYDROCHLORIDE @ HIKMA MAPLE

MYLAN INSTITUTIONAL

100MG/ML

100MG/ML

A080575

A091623

001

001 Jun 25, 2012

Oct

Jun

CAHN

NEWA

TIAGABINE HYDROCHLORIDE

TABLET; ORAL GABITRIL @ CEPHALON

@

6MG

8MG

N020646

N020646

006

007

Nov 29, 2005

Nov 29, 2005

Jan

Jan

DISC

DISC

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 125: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-116

TABLET; ORAL GABITRIL @ CEPHALON 10MG N020646 008 Nov 29, 2005 Jan DISC

TICLOPIDINE HYDROCHLORIDE

TABLET; ORAL TICLOPIDINE HYDROCHLORIDE @ SANDOZ 250MG A075326 001 Aug 20, 1999 Oct DISC

TINIDAZOLE

AB

AB

AB

AB

AB

AB

TABLET; ORAL TINDAMAX

MISSION PHARMA

+

TINIDAZOLE NOVEL LABS INC

ROXANE

250MG

500MG

250MG

500MG

250MG

500MG

N021618

N021618

A202044

A202044

A201172

A201172

001

002

001

002

001

002

May 17, 2004

May 17, 2004

Apr 30, 2012

Apr 30, 2012

Apr 30, 2012

Apr 30, 2012

Apr

Apr

Apr

Apr

Apr

Apr

CFTG

CFTG

NEWA

NEWA

NEWA

NEWA

TINZAPARIN SODIUM

INJECTABLE; INJECTION INNOHEP @ LEO PHARMA AS 20,000 IU/ML N020484 001 Jul 14, 2000 Jun DISC

TIZANIDINE HYDROCHLORIDE

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

CAPSULE; ORAL TIZANIDINE HYDROCHLORIDE

APOTEX INC EQ 2MG BASE

EQ 4MG BASE

EQ 6MG BASE

MYLAN LABS EQ 2MG BASE

EQ 4MG BASE

EQ 6MG BASE

ZANAFLEX ACORDA EQ 2MG BASE

EQ 4MG BASE

+ EQ 6MG BASE

TABLET; ORAL TIZANIDINE HYDROCHLORIDE

MYLAN PHARMS INC EQ 2MG BASE

EQ 4MG BASE

PROSAM LABS EQ 2MG BASE

EQ 4MG BASE

SANDOZ INC EQ 2MG BASE

UNICHEM LABS LTD EQ 2MG BASE

EQ 4MG BASE

A078868

A078868

A078868

A091502

A091502

A091502

N021447

N021447

N021447

A076282

A076282

A076281

A076281

A076280

A091283

A091283

001

002

003

001

002

003

001

002

003

001

002

001

002

001

001

002

Feb 03, 2012

Feb 03, 2012

Feb 03, 2012

Nov 09, 2012

Nov 09, 2012

Nov 09, 2012

Aug 29, 2002

Aug 29, 2002

Aug 29, 2002

Dec 16, 2003

Dec 16, 2003

Oct 20, 2003

Oct 20, 2003

Nov 26, 2002

Nov 28, 2012

Nov 28, 2012

Jan

Jan

Jan

Oct

Oct

Oct

Jan

Jan

Jan

Sep

Sep

Feb

Feb

Feb

Nov

Nov

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CFTG

CFTG

CFTG

CAHN

CAHN

CMFD

CMFD

NEWA

NEWA

NEWA

TOBRAMYCIN

>D>

>A>

SOLUTION; INHALATION BETHKIS

CHIESI PHARMS INC

CORNERSTONE THERAP

300MG/4ML

300MG/4ML

300MG/4ML

N201820

N201820

N201820

001

001

001

Oct 12, 2012

Oct 12, 2012

Oct 12, 2012

Nov

Oct

Nov

CAHN

NEWA

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 126: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-117

TOBRAMYCIN SULFATE

AP

AP

INJECTABLE; INJECTION TOBRAMYCIN SULFATE @ APOTHECON

@ HIKMA MAPLE

@

@

@

PFIZER

EQ 10MG BASE/ML

EQ 10MG BASE/ML

EQ 10MG BASE/ML

EQ 40MG BASE/ML

EQ 40MG BASE/ML

EQ 40MG BASE/ML

EQ 40MG BASE/ML

A064021

A063128

A063113

A063118

A063117

A063127

A065407

001

001

001

001

001

001

001

May 31, 1994

Nov 27, 1991

Apr 26, 1991

Jul 29, 1991

Apr 26, 1991

Nov 27, 1991

Mar 11, 2008

Sep

Oct

Oct

Oct

Oct

Oct

Sep

DISC

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

>A> TOFACITINIB CITRATE

>A> >A> >A>

TABLET; ORAL XELJANZ

+ PFIZER EQ 5MG BASE N203214 001 Nov 06, 2012 Nov NEWA

TOLBUTAMIDE

TABLET; ORAL TOLBUTAMIDE

+ MYLAN PHARMS INC

@ WATSON LABS

@

500MG

500MG

500MG

A086445

A087318

A086109

001

001

001

Mar

Mar

Mar

CRLD

DISC

DISC

TOLCAPONE

TABLET; ORAL TASMAR

+ VALEANT PHARMS LLC

@

100MG

200MG

N020697

N020697

001

002

Jan 29, 1998

Jan 29, 1998

May

May

CAHN

CAHN

TOLTERODINE TARTRATE

>A>

>A>

AB

AB

AB

AB

AB

AB

TABLET; ORAL DETROL

PHARMACIA AND UPJOHN

+

TOLTERODINE TARTRATE APOTEX CORP

MYLAN PHARMS INC

1MG

2MG

1MG

2MG

1MG

2MG

N020771

N020771

A200164

A200164

A202641

A202641

001

002

001

002

001

002

Mar 25, 1998

Mar 25, 1998

Sep 25, 2012

Sep 25, 2012

Nov 27, 2012

Nov 27, 2012

Sep

Sep

Sep

Sep

Nov

Nov

CFTG

CFTG

NEWA

NEWA

NEWA

NEWA

TOPOTECAN HYDROCHLORIDE

AP

AP

INJECTABLE; INJECTION TOPOTECAN HYDROCHLORIDE

INNOPHARMA INC

ONCO THERAPIES LTD

EQ 4MG BASE/VIAL

EQ 4MG BASE/VIAL

A201166

A091542

001

001

Aug 08, 2012

Aug 28, 2012

Jul

Aug

NEWA

NEWA

TRAMADOL HYDROCHLORIDE

>A> AB

AB

AB2

TABLET; ORAL TRAMADOL HYDROCHLORIDE

IPCA LABS LTD 50MG

MYLAN PHARMS INC 50MG

@ SANDOZ 50MG

TABLET, EXTENDED RELEASE; ORAL TRAMADOL HYDROCHLORIDE

ACTAVIS 100MG

A201973

A075980

A075968

A091609

001

001

001

001

Nov 16, 2012

Nov 21, 2002

Jun 25, 2002

Jun 27, 2012

Nov

Sep

Aug

Jun

NEWA

CAHN

DISC

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 127: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-118

TABLET, EXTENDED RELEASE; ORAL TRAMADOL HYDROCHLORIDE

AB2

AB2

AB2

AB2

AB2

ACTAVIS

ANCHEN PHARMS

200MG

300MG

100MG

200MG

300MG

A091609

A091609

A200491

A200491

A200491

002

003

001

002

003

Jun 27, 2012

Jun 27, 2012

Jun 27, 2012

Jun 27, 2012

Jun 27, 2012

Jun

Jun

Jun

Jun

Jun

NEWA

NEWA

NEWA

NEWA

NEWA

TABLET, ORALLY DISINTEGRATING; ORAL RYBIX ODT

+ SHIONOGI INC 50MG N021693 001 May 05, 2005 Mar CTNA

TRANEXAMIC ACID

INJECTABLE; INJECTION TRANEXAMIC ACID

AP

AP

AP

APP PHARMS LLC

LUITPOLD

NEXUS PHARMS

100MG/ML

100MG/ML

100MG/ML

A091596

A201885

A091596

001

001

001

Mar 02, 2012

Aug 10, 2011

Mar 02, 2012

May

Sep

Feb

CAHN

CAHN

NEWA

TRANYLCYPROMINE SULFATE

TABLET; ORAL PARNATE

AB + COVIS PHARMA EQ 10MG BASE N012342 003 Aug 16, 1985 Jan CAHN

TRAZODONE HYDROCHLORIDE

TABLET; ORAL TRAZODONE HYDROCHLORIDE

AB

AB

AB

AB

MYLAN PHARMS INC 50MG

100MG

150MG

300MG

A090514

A090514

A090514

A090514

001

002

003

004

Jun 02, 2009

Jun 02, 2009

Jun 02, 2009

Jun 02, 2009

Sep

Sep

Sep

Sep

CAHN

CAHN

CAHN

CAHN

TRETINOIN

CAPSULE; ORAL TRETINOIN

AB

AB +

ANCHEN PHARMS

BARR LABS INC

10MG

10MG

A201687

A077684

001

001

Oct 24, 2012

Jun 22, 2007

Oct

Oct

NEWA

CTEC

CREAM; TOPICAL AVITA

AB MYLAN PHARMS INC

RENOVA

0.025% N020404 003 Jan 14, 1997 Jun CAHN

AB2

+

+

VALEANT INTL

RETIN-A

0.02%

0.05%

N021108

N019963

001

001

Aug 31, 2000

Dec 29, 1995

Jan

Jan

CAHN

CAHN

AB

AB1

+

+

VALEANT INTL 0.025%

0.05%

N019049

N017522

001

001

Sep 16, 1988 Jan

Jan

CAHN

CAHN

AB + 0.1% N017340 001 Jan CAHN

TRETINOIN AB

AB1

AB

AB2

PRECISION DERMAT

+

SUNEVA MEDCL

GEL; TOPICAL RETIN-A

0.025%

0.0375%

0.05%

0.075%

0.1%

0.05%

A075264

A090098

A075265

A202209

A075213

A076498

001

001

001

001

001

001

Dec 24, 1998

Mar 22, 2010

Dec 24, 1998

Oct 11, 2012

Dec 24, 1998

Sep 15, 2005

May

May

May

Sep

May

May

CAHN

CAHN

CAHN

NEWA

CAHN

CAHN

AB + VALEANT INTL 0.01% N017955 001 Jan CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 128: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-119

AB

GEL; TOPICAL RETIN-A

+ VALEANT INTL 0.025% N017579 002 Jan CAHN

TRETINOIN AB

AB

PRECISION DERMAT

SOLUTION; TOPICAL RETIN-A

0.01%

0.025%

A075589

A075529

001

001

Jun 11, 2002

Feb 22, 2000

May

May

CAHN

CAHN

AT + VALEANT INTL 0.05% N016921 001 Jan CAHN

SWAB; TOPICAL RETIN-A @ VALEANT INTL 0.05% N016921 002 Jan CAHN

TRIAMCINOLONE ACETONIDE

AEROSOL, METERED; INHALATION AZMACORT

AT

@ ABBOTT

CREAM; TOPICAL TRIAMCINOLONE ACETONIDE

FOUGERA PHARMS

0.1MG/INH

0.025%

N018117

A085692

001

001

Apr 23, 1982 May

Jan

DISC

CAHN

AT 0.1% A085692 003 Jan CAHN

AT + 0.5% A085692 002 Jan CAHN

LOTION; TOPICAL TRIAMCINOLONE ACETONIDE

AT

AT

AT

FOUGERA PHARMS

+ MORTON GROVE

OINTMENT; TOPICAL TRIAMCINOLONE ACETONIDE

0.025%

0.1%

0.025%

A040467

A040467

A088450

001

002

001

Apr 21, 2003

Apr 21, 2003

Apr 01, 1985

Jan

Jan

Oct

CAHN

CAHN

CRLD

AT FOUGERA PHARMS 0.025% A085691 001 Jan CAHN

AT 0.1% A085691 003 Jan CAHN

AT 0.5% A085691 002 Jan CAHN

SPRAY, METERED; NASAL TRIAMCINOLONE ACETONIDE

AB TEVA PHARMS 0.055MG/SPRAY A078104 001 Jul 30, 2009 Mar CAHN

TRIAZOLAM

TABLET; ORAL TRIAZOLAM

AB

AB

MYLAN PHARMS INC 0.125MG

0.25MG

A074031

A074031

001

002

Mar 25, 1994

Mar 25, 1994

Sep

Sep

CAHN

CAHN

TRIFLURIDINE

SOLUTION/DROPS; OPHTHALMICTRIFLURIDINE

AT ALCON PHARMS LTD 1% A074311 001 Oct 06, 1995 Sep CAHN

TRIMETHOBENZAMIDE HYDROCHLORIDE

INJECTABLE; INJECTION TRIMETHOBENZAMIDE HYDROCHLORIDE @ HOSPIRA 100MG/ML A088804 001 Apr 03, 1987 Jun DISC

TROSPIUM CHLORIDE

AB

CAPSULE, EXTENDED RELEASE; ORAL SANCTURA XR

+ ALLERGAN 60MG N022103 001 Aug 03, 2007 Sep CFTG

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 129: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-120

CAPSULE, EXTENDED RELEASE; ORAL TROSPIUM CHLORIDE

AB WATSON LABS INC FL 60MG A091289 001 Oct 12, 2012 Sep NEWA

VALACYCLOVIR HYDROCHLORIDE

TABLET; ORAL VALACYCLOVIR HYDROCHLORIDE

AB

AB

AB

AB

JUBILANT ORGANOSYS

MYLAN PHARMS INC

EQ 500MG BASE

EQ 1GM BASE

EQ 500MG BASE

EQ 1GM BASE

A201506

A201506

A078518

A078518

001

002

001

002

Apr 03, 2012

Apr 03, 2012

May 24, 2010

May 24, 2010

Mar

Mar

Sep

Sep

NEWA

NEWA

CAHN

CAHN

VALGANCICLOVIR HYDROCHLORIDE

FOR SOLUTION; ORAL VALCYTE

+ HOFFMANN LA ROCHE

TABLET; ORAL VALCYTE

50MG/ML N022257 001 Aug 28, 2009 May CAHN

+ HOFFMANN LA ROCHE EQ 450MG BASE N021304 001 Mar 29, 2001 May CAHN

VANCOMYCIN HYDROCHLORIDE

CAPSULE; ORAL VANCOCIN HYDROCHLORIDE

AB

AB +

VIROPHARMA EQ 125MG BASE

EQ 250MG BASE

VANCOMYCIN HYDROCHLORIDE

N050606

N050606

001

002

Apr 15, 1986

Apr 15, 1986

Mar

Mar

CFTG

CFTG

AB

AB

AB

AB

AB

AB

AB

AB

AKORN

APP PHARMS LLC

STRIDES ARCOLAB LTD

WATSON LABS

INJECTABLE; INJECTION VANCOLED

EQ 125MG BASE

EQ 250MG BASE

EQ 125MG BASE

EQ 250MG BASE

EQ 125MG BASE

EQ 250MG BASE

EQ 125MG BASE

EQ 250MG BASE

A065478

A065478

A065453

A065453

A065490

A065490

A065510

A065510

001

002

001

002

001

002

001

002

Apr 09, 2012

Apr 09, 2012

Jun 18, 2012

Jun 18, 2012

Apr 09, 2012

Apr 09, 2012

Apr 09, 2012

Apr 09, 2012

Mar

Mar

Jun

Jun

Mar

Mar

Mar

Mar

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

@ HIKMA MAPLE EQ 500MG BASE/VIAL

@ EQ 1GM BASE/VIAL

@ EQ 2GM BASE/VIAL

@ EQ 5GM BASE/VIAL

@ EQ 10GM BASE/VIAL

VANCOMYCIN HYDROCHLORIDE

A062682

A062682

A062682

A062682

A062682

001

002

003

004

005

Jul 22, 1986

Mar 30, 1988

May 11, 1988

May 11, 1988

May 11, 1988

Oct

Oct

Oct

Oct

Oct

CAHN

CAHN

CAHN

CAHN

CAHN

AP

AP

AP

@ HIKMA MAPLE

@

SAGENT PHARMS

SANDOZ INC

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

A062879

A062879

A200837

A201048

A201048

001

002

001

001

002

Aug 02, 1988

Aug 02, 1988

Aug 10, 2012

Aug 10, 2012

Aug 10, 2012

Oct

Oct

Jul

Jul

Jul

CAHN

CAHN

NEWA

NEWA

NEWA

VANDETANIB

TABLET; ORAL CAPRELSA

+

IPR PHARMS INC 100MG

300MG

N022405

N022405

001

002

Apr 06, 2011

Apr 06, 2011

Feb

Feb

CTNA

CTNA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 130: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-121

VARDENAFIL HYDROCHLORIDE

TABLET; ORAL LEVITRA

AB

AB

AB

AB +

BAYER HLTHCARE 2.5MG

5MG

10MG

20MG

VARDENAFIL HYDROCHLORIDE

N021400

N021400

N021400

N021400

003

001

002

004

Aug 19, 2003

Aug 19, 2003

Aug 19, 2003

Aug 19, 2003

Apr

Apr

Apr

Apr

CFTG

CFTG

CFTG

CFTG

AB

AB

AB

AB

TEVA PHARMS 2.5MG

5MG

10MG

20MG

A091347

A091347

A091347

A091347

001

002

003

004

May 03, 2012

May 03, 2012

May 03, 2012

May 03, 2012

Apr

Apr

Apr

Apr

NEWA

NEWA

NEWA

NEWA

VECURONIUM BROMIDE

INJECTABLE; INJECTION VECURONIUM BROMIDE

>D>

>A>

AP

AP

AP

AP

+

+

BEDFORD

@ HIKMA MAPLE

@

SUN PHARMA GLOBAL

10MG/VIAL

20MG/VIAL

20MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

A075549

A075549

A075549

A075549

A075218

A075218

A079001

A079001

001

002

002

002

001

002

001

002

Jun 13, 2000

Jun 13, 2000

Jun 13, 2000

Jun 13, 2000

Aug 23, 1999

Aug 23, 1999

Jun 17, 2009

Jun 17, 2009

Jun

Nov

Nov

Jun

Oct

Oct

Jun

Jun

CRLD

CTEC

CTEC

CRLD

CAHN

CAHN

CRLD

CRLD

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL VENLAFAXINE HYDROCHLORIDE

AB

AB

AB

ANCHEN PHARMS EQ 37.5MG BASE

EQ 75MG BASE

EQ 150MG BASE

A078087

A078087

A078087

001

002

003

Mar 16, 2012

Mar 16, 2012

Mar 16, 2012

Mar

Mar

Mar

NEWA

NEWA

NEWA

TABLET; ORAL VENLAFAXINE HYDROCHLORIDE

AB

AB

AB

AB

AB

HERITAGE PHARMS INC EQ 25MG BASE

EQ 37.5MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

A078554

A078554

A078554

A078554

A078554

001

002

003

004

005

Jan 09, 2009

Jan 09, 2009

Jan 09, 2009

Jan 09, 2009

Jan 09, 2009

Aug

Aug

Aug

Aug

Aug

CAHN

CAHN

CAHN

CAHN

CAHN

VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL CALAN SR

AB

AB

AB

+

+

+

PFIZER

VERAPAMIL HYDROCHLORIDE

120MG

180MG

240MG

N019152

N019152

N019152

003

002

001

Mar 06, 1991

Dec 15, 1989

Dec 16, 1986

Feb

Feb

Feb

CTNA

CTNA

CTNA

AB

AB

AB

APOTEX CORP 120MG

180MG

240MG

A200878

A200878

A200878

001

002

003

Apr 20, 2012

Apr 20, 2012

Apr 20, 2012

Apr

Apr

Apr

NEWA

NEWA

NEWA

VIGABATRIN

FOR SOLUTION; ORAL SABRIL

+ LUNDBECK LLC 500MG/PACKET N022006 001 Aug 21, 2009 Apr CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 131: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-122

TABLET; ORAL SABRIL

+ LUNDBECK LLC 500MG N020427 001 Aug 21, 2009 Apr CAHN

VILAZODONE HYDROCHLORIDE

TABLET; ORAL VIIBRYD

+ FOREST LABS INC 10MG

40MG

N022567

N022567

001

003

Jan 21, 2011

Jan 21, 2011

Apr

Apr

CRLD

CRLD

VINCRISTINE SULFATE

INJECTABLE, LIPOSOMAL; INTRAVENOUS MARQIBO KIT

+ TALON THERAP 5MG/5ML (1MG/ML) N202497 001 Aug 09, 2012 Aug NEWA

VINORELBINE

AP

INJECTABLE; INJECTION VINORELBINE

ONCO THERAPIES LTD EQ 10MG BASE/ML A200148 001 Aug 31, 2012 Aug NEWA

VINORELBINE TARTRATE

AP

AP

INJECTABLE; INJECTION VINORELBINE TARTRATE

HIKMA MAPLE

JIANGSU HANSOH PHARM

EQ 10MG BASE/ML

EQ 10MG BASE/ML

A075992

A091106

001

001

Jun 10, 2003

Sep 26, 2012

Oct

Sep

CAHN

NEWA

VISMODEGIB

CAPSULE; ORAL ERIVEDGE

+ GENENTECH 150MG N203388 001 Jan 30, 2012 Jan NEWA

VORICONAZOLE

AP

AP

AB

AB

AB

AB

INJECTABLE; IV (INFUSION)VFEND

+ PFIZER

VORICONAZOLE SANDOZ INC

TABLET; ORAL VORICONAZOLE

MYLAN PHARMS INC

TEVA PHARMS

200MG/VIAL

200MG/VIAL

50MG

200MG

50MG

200MG

N021267

A090862

A090547

A090547

A091658

A091658

001

001

001

002

001

002

May 24, 2002

May 30, 2012

Apr 22, 2010

Apr 22, 2010

Apr 06, 2012

Apr 06, 2012

May

May

Oct

Oct

Mar

Mar

CFTG

NEWA

CAHN

CAHN

NEWA

NEWA

ZICONOTIDE

INJECTABLE; INTRATHECAL PRIALT @ JAZZ PHARMS COMMERCL 200MCG/2ML (100MCG/ML)

@ JAZZ PHARMS INTL 200MCG/2ML (100MCG/ML)

N021060

N021060

003

003

Dec 28, 2004

Dec 28, 2004

Mar

Jun

CAHN

CAHN

ZICONOTIDE ACETATE

INJECTABLE; INTRATHECAL PRIALT

+ JAZZ PHARMS COMMERCL

+

+

100MCG/1ML (100MCG/ML)

500MCG/5ML (100MCG/ML)

500MCG/20ML (25MCG/ML)

N021060

N021060

N021060

002

004

001

Dec 28, 2004

Dec 28, 2004

Dec 28, 2004

Mar

Mar

Mar

CAHN

CAHN

CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 132: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012 1-123

INJECTABLE; INTRATHECAL PRIALT

+

+

+

JAZZ PHARMS INTL 100MCG/1ML (100MCG/ML)

500MCG/20ML (25MCG/ML)

500MCG/5ML (100MCG/ML)

N021060

N021060

N021060

002

001

004

Dec 28, 2004

Dec 28, 2004

Dec 28, 2004

Jun

Jun

Jun

CAHN

CAHN

CAHN

ZIDOVUDINE

TABLET; ORAL ZIDOVUDINE

AB HEC PHARM USA INC 300MG A202058 001 Oct 07, 2011 Oct CAHN

AB MYLAN PHARMS INC

@ RANBAXY LABS LTD

300MG

300MG

A078922

A077327

001

001

Feb 14, 2008

Sep 19, 2005

Sep

Apr

CAHN

DISC

ZIPRASIDONE HYDROCHLORIDE

CAPSULE; ORAL GEODON

AB + PFIZER EQ 20MG BASE N020825 001 Feb 05, 2001 Feb CFTG

AB EQ 40MG BASE N020825 002 Feb 05, 2001 Feb CFTG

AB EQ 60MG BASE N020825 003 Feb 05, 2001 Feb CFTG

AB EQ 80MG BASE N020825 004 Feb 05, 2001 Feb CFTG

ZIPRASIDONE HYDROCHLORIDE AB APOTEX CORP EQ 20MG BASE A077561 001 Mar 02, 2012 Feb NEWA

AB EQ 40MG BASE A077561 002 Mar 02, 2012 Feb NEWA

AB EQ 60MG BASE A077561 003 Mar 02, 2012 Feb NEWA

AB EQ 80MG BASE A077561 004 Mar 02, 2012 Feb NEWA

AB DR REDDYS LABS INC EQ 20MG BASE A077565 001 Mar 02, 2012 Feb NEWA

AB EQ 40MG BASE A077565 002 Mar 02, 2012 Feb NEWA

AB EQ 60MG BASE A077565 003 Mar 02, 2012 Feb NEWA

AB EQ 80MG BASE A077565 004 Mar 02, 2012 Feb NEWA

AB LUPIN PHARMS EQ 20MG BASE A077560 001 Mar 02, 2012 Feb NEWA

AB EQ 40MG BASE A077560 002 Mar 02, 2012 Feb NEWA

AB EQ 60MG BASE A077560 003 Mar 02, 2012 Feb NEWA

AB EQ 80MG BASE A077560 004 Mar 02, 2012 Feb NEWA

AB

AB

AB

SANDOZ INC EQ 20MG BASE

EQ 40MG BASE

EQ 60MG BASE

A077562

A077562

A077562

001

002

003

Jun 01, 2012

Jun 01, 2012

Jun 01, 2012

May

May

May

NEWA

NEWA

NEWA

AB EQ 80MG BASE A077562 004 Jun 01, 2012 May NEWA

AB WOCKHARDT LTD EQ 20MG BASE A090348 001 Sep 05, 2012 Aug NEWA

AB EQ 40MG BASE A090348 002 Sep 05, 2012 Aug NEWA

AB

AB

EQ 60MG BASE

EQ 80MG BASE

A090348

A090348

003

004

Sep 05, 2012

Sep 05, 2012

Aug

Aug

NEWA

NEWA

ZOLPIDEM TARTRATE

TABLET; ORAL ZOLPIDEM TARTRATE

AB CIPLA LTD 5MG A077388 001 Jul 30, 2012 Jul NEWA

AB 10MG A077388 002 Jul 30, 2012 Jul NEWA

@ MYLAN PHARMS INC 5MG A078016 001 Apr 23, 2007 Oct DISC

@ 10MG A078016 002 Apr 23, 2007 Oct DISC

ZONISAMIDE

CAPSULE; ORAL ZONISAMIDE

AB MYLAN PHARMS INC 25MG A077647 001 Dec 22, 2005 Sep CAHN

AB 50MG A077647 002 Dec 22, 2005 Sep CAHN

AB 100MG A077647 003 Dec 22, 2005 Sep CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 133: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

2-1

OTC DRUG PRODUCT LIST - 32ND EDITION

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

TABLET, CHEWABLE; ORAL PEPCID COMPLETE

+ MCNEIL CONS 800MG;10MG;165MG N020958 001 Oct 16, 2000 Mar CAHN

CETIRIZINE HYDROCHLORIDE

>A>

>A>

SYRUP; ORAL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

@ RANBAXY LABS LTD 5MG/5ML

TRIS PHARMA INC 5MG/5ML

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF @ RANBAXY LABS LTD 5MG/5ML

TRIS PHARMA INC 5MG/5ML

TABLET, CHEWABLE; ORAL CHILDREN'S ZYRTEC ALLERGY

MCNEIL CONS 5MG

+ 10MG

CHILDREN'S ZYRTEC HIVES RELIEF MCNEIL CONS 5MG

+ 10MG

TABLET; ORAL CETIRIZINE HYDROCHLORIDE ALLERGY

@ ACTAVIS ELIZABETH 5MG

@ 10MG

A090183

A090572

A090183

A090572

N021621

N021621

N021621

N021621

A078615

A078615

002

001

001

002

003

004

005

006

003

004

Apr 24, 2008

Nov 16, 2012

Apr 24, 2008

Nov 16, 2012

Nov 16, 2007

Nov 16, 2007

Nov 16, 2007

Nov 16, 2007

Dec 28, 2007

Dec 28, 2007

Jul

Nov

Jul

Nov

Oct

Oct

Oct

Oct

Oct

Oct

DISC

NEWA

DISC

NEWA

CAHN

CAHN

CAHN

CAHN

DISC

DISC

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

SUN PHARM INDS LTD 5MG;120MG A090922 001 Sep 28, 2012 Sep NEWA

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

SWAB; TOPICAL CHLORAPREP ONE-STEP SEPP

+ CAREFUSION 2%;70% (0.67ML)

CHLORAPREP SINGLE SWABSTICK + CAREFUSION 2%;70% (1.75ML)

CHLORAPREP TRIPLE SWABSTICK + CAREFUSION 2%;70% (5.25ML)

CHLORASCRUB MAXI SWABSTICK + PROF DSPLS 3.15%;70% (5.1ML)

CHLORASCRUB SWAB + PROF DSPLS 3.15%;70% (1ML)

CHLORASCRUB SWABSTICK

+ PROF DSPLS 3.15%;70% (1.6ML)

N021555

N021555

N021555

N021524

N021524

N021524

001

002

003

003

001

002

Oct 07, 2002

May 10, 2005

Jun 10, 2009

Jun 03, 2005

Jun 03, 2005

Jun 03, 2005

Aug

Aug

Aug

Mar

Mar

Mar

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

DEXTROMETHORPHAN POLISTIREX

SUSPENSION, EXTENDED RELEASE; ORAL DEXTROMETHORPHAN POLISTIREX

TRIS PHARMA INC EQ 30MG HBR/5ML A091135 001 May 25, 2012 May NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 134: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

2-2 OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

CAPSULE; ORAL IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

STRIDES ARCOLAB LTD 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

A200888 001

FAMOTIDINE

TABLET, CHEWABLE; ORAL PEPCID AC @ MCNEIL CONS 10MG

+ 20MG

N020801

N020801

001

002

TABLET; ORAL FAMOTIDINE @ SANDOZ 10MG

PEPCID AC

A076101 001

MCNEIL CONS 10MG N020325 001

+ 20MG N020325 002

PEPCID AC (GELTAB)MCNEIL CONS 10MG N020902 001

FEXOFENADINE HYDROCHLORIDE

TABLET; ORAL CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

SUN PHARM INDS 30MG A091567 002

WOCKHARDT LTD 30MG A079112 002

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES SUN PHARM INDS 30MG A091567 001

WOCKHARDT LTD 30MG A079112 001

FEXOFENADINE HYDROCHLORIDE ALLERGY SUN PHARM INDS 60MG A091567 004

180MG A091567 006

WOCKHARDT LTD 60MG A079112 004

180MG A079112 006

FEXOFENADINE HYDROCHLORIDE HIVES SUN PHARM INDS 60MG A091567 003

180MG A091567 005

WOCKHARDT LTD 60MG A079112 003

180MG A079112 005

IBUPROFEN

>A>

CAPSULE; ORAL ADVIL LIQUI-GELS

+ PFIZER EQ 200MG FREE ACID AND POTASSIUM SALT

N020402 001

>D> + WYETH CONS EQ 200MG FREE ACID AND POTASSIUM SALT

N020402 001

>A> ADVIL MIGRAINE LIQUI-GELS

+ PFIZER EQ 200MG FREE ACID AND POTASSIUM SALT

N020402 002

>D> + WYETH CONS EQ 200MG FREE ACID AND POTASSIUM SALT

N020402 002

IBUPROFEN ACCUCAPS INDS EQ 200MG FREE ACID AND POTASSIUM

SALT A077338 001

PLD ACQUISITIONS EQ 200MG FREE ACID AND POTASSIUM SALT

A077338 001

Mar 05, 2012

Sep 24, 1998

Dec 17, 2007

Oct 21, 2002

Apr 28, 1995

Sep 23, 2003

Aug 05, 1999

Feb 06, 2012

Feb 08, 2012

Feb 06, 2012

Feb 08, 2012

Feb 06, 2012

Feb 06, 2012

Feb 08, 2012

Feb 08, 2012

Feb 06, 2012

Feb 06, 2012

Feb 08, 2012

Feb 08, 2012

Apr 20, 1995

Apr 20, 1995

Mar 16, 2000

Mar 16, 2000

Jul 10, 2009

Jul 10, 2009

Feb NEWA

Mar CAHN

Mar CAHN

Oct DISC

Mar CAHN

Mar CAHN

Mar CAHN

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Jan CAHN

Oct CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 135: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

2-3 OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

SUSPENSION/DROPS; ORALPEDIATRIC ADVIL

>A>

>D>

+ PFIZER

+ WYETH CONS

SUSPENSION; ORAL CHILDREN'S ADVIL

100MG/2.5ML

100MG/2.5ML

N020812

N020812

001

001

Jan 30, 1998

Jan 30, 1998

Nov

Nov

CAHN

CAHN

>A>

>D>

PFIZER 100MG/5ML

WYETH CONS 100MG/5ML

CHILDREN'S ADVIL-FLAVORED

N020589

N020589

001

001

Jun 27, 1996

Jun 27, 1996

Nov

Nov

CAHN

CAHN

>A>

>D>

PFIZER

WYETH CONS

TABLET, CHEWABLE; ORAL CHILDREN'S ADVIL

100MG/5ML

100MG/5ML

N020589

N020589

002

002

Nov 07, 1997

Nov 07, 1997

Nov

Nov

CAHN

CAHN

>A>

>D>

PFIZER

WYETH CONS

JUNIOR STRENGTH ADVIL

50MG

50MG

N020944

N020944

001

001

Dec 18, 1998

Dec 18, 1998

Nov

Nov

CAHN

CAHN

>A>

>D>

PFIZER

WYETH CONS

TABLET; ORAL IBUPROFEN

100MG

100MG

N020944

N020944

002

002

Dec 18, 1998

Dec 18, 1998

Nov

Nov

CAHN

CAHN

@ CONTRACT PHARMACAL

JUNIOR STRENGTH ADVIL

200MG A073691 001 Feb 25, 1994 Oct DISC

>A>

>D>

PFIZER

WYETH CONS

100MG

100MG

N020267

N020267

002

002

Dec 13, 1996

Dec 13, 1996

Nov

Nov

CAHN

CAHN

IBUPROFEN SODIUM

TABLET; ORAL ADVIL

+ PFIZER CONS HLTHCARE EQ 200MG BASE N201803 001 Jun 12, 2012 Jun NEWA

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS; ORAL LANSOPRAZOLE

DR REDDYS LABS LTD

PERRIGO R AND D

WOCKHARDT LTD

PREVACID 24 HR

15MG

15MG

15MG

A202194

A202319

A202727

001

001

001

May 18, 2012

May 18, 2012

May 18, 2012

Apr

Apr

Apr

NEWA

NEWA

NEWA

+ NOVARTIS 15MG N022327 001 May 18, 2009 Apr CFTG

LEVONORGESTREL

TABLET; ORAL LEVONORGESTREL

WATSON LABS INC

PLAN B

1.5MG A200670 001 Jul 12, 2012 Jun NEWA

+ TEVA BRANDED PHARM

PLAN B ONE-STEP

0.75MG N021045 002 Aug 24, 2006 May CAHN

+ DURAMED 1.5MG N021998 001 Jul 10, 2009 Jun CFTG

LORATADINE

SYRUP; ORAL LORATADINE @ RANBAXY LABS LTD 1MG/ML

TABLET, ORALLY DISINTEGRATING; ORAL ALAVERT

A076529 001 Aug 20, 2004 Jul DISC

>A> PFIZER 10MG N021375 001 Dec 19, 2002 Nov CAHN

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 136: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

2-4 OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

>D>

>A>

>D>

TABLET, ORALLY DISINTEGRATING; ORAL ALAVERT

WYETH CONS 10MG

LORATADINE

PFIZER 10MG

WYETH CONS 10MG

N021375

A075822

A075822

001

001

001

Dec 19, 2002

Feb 10, 2003

Feb 10, 2003

Nov

Nov

Nov

CAHN

CAHN

CAHN

>A>

MENTHOL; METHYL SALICYLATE

PATCH; TOPICAL SALONPAS

HISAMITSU PHARM CO 3%;10% N022029 002 Nov 05, 2012 Nov NEWA

NAPROXEN SODIUM

TABLET; ORAL NAPROXEN SODIUM @ SANDOZ EQ 200MG BASE A074646 001 Jan 13, 1997 Oct DISC

NICOTINE

FILM, EXTENDED RELEASE; TRANSDERMAL NICOTINE

AVEVA 7MG/24HR

14MG/24HR

A074612

A074612

002

003

Jul 28, 2003

Oct 20, 1997

Apr

Apr

NEWA

NEWA

NICOTINE POLACRILEX

TROCHE/LOZENGE; ORALNICOTINE POLACRILEX

PERRIGO R AND D EQ 2MG BASE

EQ 4MG BASE

A203690

A203690

001

002

Oct 09, 2012

Oct 09, 2012

Sep

Sep

NEWA

NEWA

NIZATIDINE

>A>

>D>

TABLET; ORAL AXID AR

+ PFIZER

+ WYETH CONS

75MG

75MG

N020555

N020555

001

001

May 09, 1996

May 09, 1996

Nov

Nov

CAHN

CAHN

POLYETHYLENE GLYCOL 3350

FOR SOLUTION; ORAL POLYETHYLENE GLYCOL 3350 @ PADDOCK LLC 17GM/SCOOPFUL A090567 001 Oct 15, 2009 Sep DISC

POTASSIUM IODIDE

SOLUTION; ORAL THYROSHIELD

+ ARCO PHARMS LLC 65MG/ML A077218 001 Jan 12, 2005 Oct CAHN

RANITIDINE HYDROCHLORIDE

TABLET; ORAL RANITIDINE HYDROCHLORIDE

APOTEX INC EQ 150MG BASE

SHASUN CHEMS EQ 75MG BASE

A200172

A201745

001

001

May 31, 2012

Feb 29, 2012

May

Feb

NEWA

NEWA

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 137: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

3-1

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

CUMULATIVE SUPPLEMENT NUMBER 11 NOVMEBER 2012

NO NOVEMBER 2012 APPROVALS

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 138: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

4-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at:

http://www.fda.gov/orphan/designat/list.htm

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 139: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

5-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

NO NOVEMBER 2012 ADDITIONS

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 140: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 32ND EDITION A - 1

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

ABACAVIR SULFATE - ABACAVIR SULFATE

A091294 001 PC Dec 16, 2012

ACETYLCYSTEINE - ACETADOTE

N021539 001 8148356 May 21, 2026 DP

ACETYLCYSTEINE - ACETYLCYSTEINE

A200644 001 PC>A> May 29, 2013

ACLIDINIUM BROMIDE - TUDORZA PRESSAIR

N202450 001 5840279 Jun 21, 2016 DP NCE Jul 23, 2017

6071498 Jun 21, 2016 DP

6681768 Aug 07, 2022 DP

6750226 Sep 05, 2020 DS DP U-1264

7078412 Jul 16, 2020 DS DP U-1263

8051851 Apr 22, 2027 DP

ADAPALENE; BENZOYL PEROXIDE - EPIDUO

N022320 001 8105618 Dec 23, 2022 U-1078

8129362 Jul 18, 2027 U-1078

8241649 Dec 23, 2022 DP

ALBUMIN HUMAN - OPTISON

N020899 001 M-120 Aug 17, 2015

ALBUTEROL SULFATE - PROAIR HFA

N021457 001 6446627 Dec 18, 2017 DP

8132712 Sep 07, 2028 DP

ALBUTEROL SULFATE - VENTOLIN HFA

N020983 001 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

ALCAFTADINE - LASTACAFT

N022134 001 5468743 Nov 21, 2013 DS DP

ALENDRONATE SODIUM - BINOSTO

N202344 001 7488496 Aug 11, 2023 DS DP

7964212 Mar 06, 2023 DS DP

ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA

N022217 001 8168616 Jul 05, 2025 DP

ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA

N022217 002 8168616 Jul 05, 2025 DP

ALVIMOPAN - ENTEREG

N021775 001 8112290 Jul 31, 2030 U-1225

AMBRISENTAN - LETAIRIS

N022081 001 5840722>A> Nov 24, 2015 U-821

5840722>A> Nov 24, 2015 U-1297

RE42462 Jul 29, 2018 DS

AMBRISENTAN - LETAIRIS

N022081 002 5840722>A> Nov 24, 2015 U-821

5840722>A> Nov 24, 2015 U-1297

RE42462 Jul 29, 2018 DS

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 141: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 2

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE CODES REQUESTED CODE(S) DATENO PATENT NO

AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN

N020965 001 8216289 May 01, 2018 U-289

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT

N022314 001 8101599 May 16, 2023 DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT

N022314 002 8101599 May 16, 2023 DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT

N022314 003 8101599 May 16, 2023 DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT

N022314 004 8101599 May 16, 2023 DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT

N022314 005 8101599 May 16, 2023 DP

AMOXICILLIN - MOXATAG

N050813 001 >A> 8299052 May 07, 2027 U-1304

APREPITANT - EMEND

N021549 001 8258132 Sep 26, 2027 DP U-901

8258132 Sep 26, 2027 DP U-1282

APREPITANT - EMEND

N021549 002 8258132 Sep 26, 2027 DP U-901

8258132 Sep 26, 2027 DP U-1282

APREPITANT - EMEND

N021549 003 8258132 Sep 26, 2027 DP U-901

8258132 Sep 26, 2027 DP U-1282

ARFORMOTEROL TARTRATE - BROVANA

N021912 001 6589508 Apr 03, 2013 U-793

6667344 Jun 22, 2021 DP

6814953 Jun 22, 2021 U-793

8110706 Nov 09, 2021 DP

ARSENIC TRIOXIDE - TRISENOX

N021248 001 8273379 Nov 10, 2018 U-1291

ATOVAQUONE; PROGUANIL HYDROCHLORIDE - ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

A091211 001 PC Mar 13, 2012

AVANAFIL - STENDRA

N202276 001 6656935 Sep 13, 2020 DS DP U-155 NCE Apr 27, 2017

7501409 May 05, 2023 DP

AVANAFIL - STENDRA

N202276 002 6656935 Sep 13, 2020 DS DP U-155 NCE Apr 27, 2017

7501409 May 05, 2023 DP

AVANAFIL - STENDRA

N202276 003 6656935 Sep 13, 2020 DS DP U-155 NCE Apr 27, 2017

7501409 May 05, 2023 DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 142: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 3

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

AXITINIB - INLYTA

N202324 001 6534524 Jun 30, 2020 DS DP NCE Jan 27, 2017

7141581 Jun 30, 2020 U-1220

AXITINIB - INLYTA

N202324 002 6534524 Jun 30, 2020 DS DP NCE Jan 27, 2017

7141581 Jun 30, 2020 U-1220

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - DYMISTA

N202236 001 8163723 Aug 29, 2023 U-81

8163723 Aug 29, 2023 U-77

NC May 01, 2015

8163723 Aug 29, 2023 U-707

8163723 Aug 29, 2023 U-644

8168620 Feb 24, 2026 DP

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR

N202331 001 5583141 Dec 10, 2013 DS DP U-3

5736555 Jun 25, 2012 DS DP U-3

7157584 May 22, 2025 DS

7572920 Jan 07, 2025 DP U-3

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR

N202331 002 5583141 Dec 10, 2013 DS DP U-3

5736555 Jun 25, 2012 DS DP U-3

7157584 May 22, 2025 DS

7572920 Jan 07, 2025 DP U-3

BALSALAZIDE DISODIUM - GIAZO

N022205 001 6197341 Mar 13, 2018 DP U-1229 NDF Feb 03, 2015

7452872 Aug 24, 2026 U-1229

7625884 Aug 24, 2026 U-1229

BECLOMETHASONE DIPROPIONATE - QNASL

N202813 001 5605674 Feb 25, 2014 DP NP Mar 23, 2015

5683677 Nov 04, 2014 DP

5776432 Jul 07, 2015 DP

7780038 Jan 24, 2027 DP

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N022249 001 NCE ODE PED PED

Mar 20, 2013Mar 20, 2015Sep 20, 2015Sep 20, 2013

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N022249 002 NCE ODE PED PED

Mar 20, 2013Mar 20, 2015Sep 20, 2015Sep 20, 2013

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA

N050819 001 8288434 Aug 05, 2029 DP U-124

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX

N022185 001 I-659 Oct 17, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 143: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 4

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO BIMATOPROST - LATISSE

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N022369 001 8101161

8101161

8263054

May 25, 2024

May 25, 2024

Aug 25, 2023

U-1218

U-1217

U-1277

BIMATOPROST - LUMIGAN

N022184 001 8278353

8299118>A>

8309605>A>

8309605>A>

Mar

Mar

Mar

Mar

16, 2025

16, 2025

16, 2025

16, 2025

DP

U-1295

U-1294

U-1293

BIVALIRUDIN - ANGIOMAX

N020873 001 5196404

5196404

5196404*PED

Dec

Dec

Jun

15, 2014

15, 2014

15, 2015

DS DP U-1232

DS DP U-1040

BOCEPREVIR - VICTRELIS

N202258 001 8119602

RE43298

Mar

Feb

17, 2027

22, 2022

U-1233

DS DP U-1128

BORTEZOMIB - VELCADE

N021602 001 NR Jan 23, 2015

BOSUTINIB MONOHYDRATE - BOSULIF

N203341 001 6002008

7417148

7767678

7919625

RE42376

Mar 27, 2018

Jan 23, 2026

Nov 23, 2026

Dec 11, 2025

Sep 24, 2019

DS DP U-1284

U-1283

DS DP

DP

DS

NCE ODE

SepSep

04, 201704, 2019

BOSUTINIB MONOHYDRATE - BOSULIF

N203341 002 6002008

7417148

7767678

7919625

RE42376

Mar 27, 2018

Jan 23, 2026

Nov 23, 2026

Dec 11, 2025

Sep 24, 2019

DS DP U-1284

U-1283

DS DP

DP

DS

NCE ODE

SepSep

04, 201704, 2019

BRIMONIDINE TARTRATE; TIMOLOL MALEATE - COMBIGAN

N021398 001 8133890 Apr 19, 2022 U-1235

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT

N021929 001 8143239 Jan 29, 2023 DP U-1073

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT

N021929 002 8143239 Jan 29, 2023 DP U-1073

BUPIVACAINE - EXPAREL

N022496 001 6132766

8182835

Nov 16, 2013

Sep 18, 2018

DP

DP U-1246

BUPIVACAINE - EXPAREL

N022496 002 6132766

8182835

Nov 16, 2013

Sep 18, 2018

DP

DP U-1246

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE

N022410 003 NDF Aug 30, 2013

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 144: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 5

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE

N022410 004 NDF Aug 30, 2013

BUTOCONAZOLE NITRATE - BUTOCONAZOLE NITRATE

A200923 001 PC>A> May 14, 2013

CABOZANTINIB S-MALATE - COMETRIQ

N203756 001 NCE >A> Nov 29, 2017

CABOZANTINIB S-MALATE - COMETRIQ

N203756 002 NCE >A> Nov 29, 2017

CALCIPOTRIENE - SORILUX

N022563 001 8263580 May 26, 2026 DP U-1280 I-657 Sep 27, 2015

CARFILZOMIB - KYPROLIS

N202714 001 7232818

7417042

Apr 14, 2025

Jun 07, 2026

DS DP

DS DP

NCE ODE

Jul Jul

20, 201720, 2019

7491704 Apr 14, 2025 U-1260

7737112 Dec 07, 2027 DP

8129346 Dec 25, 2026 U-1260

8207125

8207126

Apr 14, 2025

Apr 14, 2025

DS DP

DP

8207127 Apr 14, 2025 U-1260

8207297 Apr 14, 2025 DS DP

CARVEDILOL PHOSPHATE - COREG CR

N022012 001 6022562 Oct 17, 2015 DP Y 8101209 Sep 11, 2025 DP

8101209*PED Mar 11, 2026

CARVEDILOL PHOSPHATE - COREG CR

N022012 002 6022562 Oct 17, 2015 DP Y 8101209 Sep 11, 2025 DP

8101209*PED Mar 11, 2026

CARVEDILOL PHOSPHATE - COREG CR

N022012 003 6022562 Oct 17, 2015 DP Y 8101209 Sep 11, 2025 DP

8101209*PED Mar 11, 2026

CARVEDILOL PHOSPHATE - COREG CR

N022012 004 6022562 Oct 17, 2015 DP Y 8101209 Sep 11, 2025 DP

8101209*PED Mar 11, 2026

CEFTAROLINE FOSAMIL - TEFLARO

N200327 001 8247400 Feb 10, 2031 DP U-282

CEFTAROLINE FOSAMIL - TEFLARO

N200327 002 8247400 Feb 10, 2031 DP U-282

CEVIMELINE HYDROCHLORIDE - CEVIMELINE

A091260 001 PC Apr 06, 2013

CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE

N021669 001 7717889 Feb 27, 2025 DP U-1022

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 145: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 6

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED CODE(S) DATENO PATENT NO CODES

CHOLINE C-11 - CHOLINE C-11

N203155 001 NCE Sep 12, 2017W Sep 12, 2017

CICLESONIDE - ZETONNA

N202129 001 5482934

5605674

5683677

5775321

6006745

6036942

6120752

6264923

Oct 24, 2017

Feb 25, 2014

Nov 04, 2014

Jul 07, 2015

Dec 28, 2016

Apr 30, 2013

May 13, 2018

May 13, 2018

DS DP U-1002

DP

DP

DP

DP

DP

DP

DP

NP Jan 20, 2015

CICLOPIROX - LOPROX

N021159 001 8227490 Sep 16, 2017 U-1256

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - PREPOPIK

N202535 001 NP Jul 16, 2015

CLEVIDIPINE BUTYRATE - CLEVIPREX

N022156 001 5856346 Jan 05, 2021 DS DP U-893

CLEVIDIPINE BUTYRATE - CLEVIPREX

N022156 002 5856346 Jan 05, 2021 DS DP U-893

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE

A078223 001 PC Jun 30, 2012

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE

A078854 001 PC Jun 30, 2012

CLOPIDOGREL BISULFATE - CLOPIDOGREL BISULFATE

A077665 002 PC Nov 13, 2012

CLOPIDOGREL BISULFATE - CLOPIDOGREL BISULFATE

A091023 001 PC Nov 13, 2012

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

N203100 001 5814639 Sep 29, 2015 DS DP

5914331 Jul 02, 2017 DS

5922695 Jul 25, 2017 U-257DS

5935946 Jul 25, 2017 DS DP U-257

5977089 Jul 25, 2017 DS DP U-257

6043230 Jul 25, 2017 U-257

6642245 Nov 04, 2020 U-257

6703396 Mar 09, 2021 DS DP

7176220 Nov 20, 2023 DS DP U-257

7635704 Jan 12, 2026 DS DP U-257

8148374 Sep 03, 2029 DS DP U-1279

- STRIBILD

COLCHICINE - COLCRYS

N022352 001 7964648

8097655

Oct

Oct

06, 2028

06, 2028

U-1161

U-1020

CRIZOTINIB - XALKORI

N202570 001 8217057 Nov 06, 2029 DS DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 146: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 7

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO CRIZOTINIB - XALKORI

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N202570 002 8217057 Nov 06, 2029 DS DP

CYSTEAMINE HYDROCHLORIDE - CYSTARAN

N200740 001 NP ODE

Oct Oct

02, 201502, 2019

DAPTOMYCIN - CUBICIN

N021572 002 8129342 Nov 28, 2020 DS DP

DARUNAVIR ETHANOLATE - PREZISTA

N021976 001 5843946>A>

5843946>A>

5843946>A>

5843946>A>

5843946>A>

5843946*PED

6037157>A>

6037157>A>

6037157>A>

6037157*PED

6335460>A>

6335460>A>

6335460>A>

6335460>A>

6335460>A>

6335460*PED

6703403>A>

6703403>A>

6703403>A>

6703403*PED

7470506>A>

7470506>A>

7470506>A>

7470506*PED

RE43596

RE43596*PED

RE43802>A>

RE43802*PED >A>

Dec 01, 2015

Dec 01, 2015

Dec 01, 2015

Dec 01, 2015

Dec 01, 2015

Jun 01, 2016

Jun 26, 2016

Jun 26, 2016

Jun 26, 2016

Dec 26, 2016

Aug 25, 2012

Aug 25, 2012

Aug 25, 2012

Aug 25, 2012

Aug 25, 2012

Feb 25, 2013

Jun 26, 2016

Jun 26, 2016

Jun 26, 2016

Dec 26, 2016

Jun 23, 2019

Jun 23, 2019

Jun 23, 2019

Dec 23, 2019

May 09, 2017

Nov 09, 2017

Oct 19, 2016

Apr 19, 2017

DP U-1305

DP U-744

DP U-903

DP U-935

DP U-1209

U-1209

U-1305

U-935

DS DP U-935

DS DP U-1209

DS DP U-1305

DS DP U-903

DS DP U-744

U-1209

U-1305

U-935

U-1209

U-1305

U-935

DS DP

U-1305

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 147: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 8

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE CODES REQUESTED CODE(S) DATENO PATENT NO

DARUNAVIR ETHANOLATE - PREZISTA

N021976 002 >A> 5843946 Dec 01, 2015 DP U-1305

>A> 5843946 Dec 01, 2015 DP U-744

>A> 5843946 Dec 01, 2015 DP U-903

>A> 5843946 Dec 01, 2015 DP U-935

>A> 5843946 Dec 01, 2015 DP U-1209

5843946*PED Jun 01, 2016

>A> 6037157 Jun 26, 2016 U-1209

>A> 6037157 Jun 26, 2016 U-1305

>A> 6037157 Jun 26, 2016 U-935

6037157*PED Dec 26, 2016

>A> 6335460 Aug 25, 2012 DS DP U-935

>A> 6335460 Aug 25, 2012 DS DP U-1209

>A> 6335460 Aug 25, 2012 DS DP U-1305

>A> 6335460 Aug 25, 2012 DS DP U-903

>A> 6335460 Aug 25, 2012 DS DP U-744

6335460*PED Feb 25, 2013

>A> 6703403 Jun 26, 2016 U-1209

>A> 6703403 Jun 26, 2016 U-1305

>A> 6703403 Jun 26, 2016 U-935

6703403*PED Dec 26, 2016

>A> 7470506 Jun 23, 2019 U-1209

>A> 7470506 Jun 23, 2019 U-1305

>A> 7470506 Jun 23, 2019 U-935

7470506*PED Dec 23, 2019

RE43596 May 09, 2017 DS DP

RE43596*PED Nov 09, 2017

>A> RE43802 Oct 19, 2016 U-1305

>A> RE43802*PED Apr 19, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 148: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 9

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE CODES REQUESTED CODE(S) DATENO PATENT NO

DARUNAVIR ETHANOLATE - PREZISTA

N021976 003 >A> 5843946 Dec 01, 2015 DP U-1305

>A> 5843946 Dec 01, 2015 DP U-744

>A> 5843946 Dec 01, 2015 DP U-903

>A> 5843946 Dec 01, 2015 DP U-935

>A> 5843946 Dec 01, 2015 DP U-1209

5843946*PED Jun 01, 2016

>A> 6037157 Jun 26, 2016 U-1209

>A> 6037157 Jun 26, 2016 U-1305

>A> 6037157 Jun 26, 2016 U-935

6037157*PED Dec 26, 2016

>A> 6335460 Aug 25, 2012 DS DP U-935

>A> 6335460 Aug 25, 2012 DS DP U-1209

>A> 6335460 Aug 25, 2012 DS DP U-1305

>A> 6335460 Aug 25, 2012 DS DP U-903

>A> 6335460 Aug 25, 2012 DS DP U-744

6335460*PED Feb 25, 2013

>A> 6703403 Jun 26, 2016 U-1209

>A> 6703403 Jun 26, 2016 U-1305

>A> 6703403 Jun 26, 2016 U-935

6703403*PED Dec 26, 2016

>A> 7470506 Jun 23, 2019 U-1209

>A> 7470506 Jun 23, 2019 U-1305

>A> 7470506 Jun 23, 2019 U-935

7470506*PED Dec 23, 2019

RE43596 May 09, 2017 DS DP

RE43596*PED Nov 09, 2017

>A> RE43802 Oct 19, 2016 U-1305

>A> RE43802*PED Apr 19, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 149: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 10

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE CODES REQUESTED CODE(S) DATENO PATENT NO

DARUNAVIR ETHANOLATE - PREZISTA

N021976 004 >A> 5843946 Dec 01, 2015 DP U-1305

>A> 5843946 Dec 01, 2015 DP U-744

>A> 5843946 Dec 01, 2015 DP U-903

>A> 5843946 Dec 01, 2015 DP U-935

>A> 5843946 Dec 01, 2015 DP U-1209

5843946*PED Jun 01, 2016

>A> 6037157 Jun 26, 2016 U-1209

>A> 6037157 Jun 26, 2016 U-1305

>A> 6037157 Jun 26, 2016 U-935

6037157*PED Dec 26, 2016

>A> 6335460 Aug 25, 2012 DS DP U-935

>A> 6335460 Aug 25, 2012 DS DP U-1209

>A> 6335460 Aug 25, 2012 DS DP U-1305

>A> 6335460 Aug 25, 2012 DS DP U-903

>A> 6335460 Aug 25, 2012 DS DP U-744

6335460*PED Feb 25, 2013

>A> 6703403 Jun 26, 2016 U-1209

>A> 6703403 Jun 26, 2016 U-1305

>A> 6703403 Jun 26, 2016 U-935

6703403*PED Dec 26, 2016

>A> 7470506 Jun 23, 2019 U-1209

>A> 7470506 Jun 23, 2019 U-1305

>A> 7470506 Jun 23, 2019 U-935

7470506*PED Dec 23, 2019

RE43596 May 09, 2017 DS DP

RE43596*PED Nov 09, 2017

>A> RE43802 Oct 19, 2016 U-1305

>A> RE43802*PED Apr 19, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 150: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 11

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE CODES REQUESTED CODE(S) DATENO PATENT NO

DARUNAVIR ETHANOLATE - PREZISTA

N021976 005 >A> 5843946 Dec 01, 2015 DP U-1305

>A> 5843946 Dec 01, 2015 DP U-744

>A> 5843946 Dec 01, 2015 DP U-903

>A> 5843946 Dec 01, 2015 DP U-935

>A> 5843946 Dec 01, 2015 DP U-1209

5843946*PED Jun 01, 2016

>A> 6037157 Jun 26, 2016 U-1209

>A> 6037157 Jun 26, 2016 U-1305

>A> 6037157 Jun 26, 2016 U-935

6037157*PED Dec 26, 2016

>A> 6335460 Aug 25, 2012 DS DP U-935

>A> 6335460 Aug 25, 2012 DS DP U-1209

>A> 6335460 Aug 25, 2012 DS DP U-1305

>A> 6335460 Aug 25, 2012 DS DP U-903

>A> 6335460 Aug 25, 2012 DS DP U-744

6335460*PED Feb 25, 2013

>A> 6703403 Jun 26, 2016 U-1209

>A> 6703403 Jun 26, 2016 U-1305

>A> 6703403 Jun 26, 2016 U-935

6703403*PED Dec 26, 2016

>A> 7470506 Jun 23, 2019 U-1209

>A> 7470506 Jun 23, 2019 U-1305

>A> 7470506 Jun 23, 2019 U-935

7470506*PED Dec 23, 2019

RE43596 May 09, 2017 DS DP

RE43596*PED Nov 09, 2017

>A> RE43802 Oct 19, 2016 U-1305

>A> RE43802*PED Apr 19, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 151: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 12

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION DELIST EXCLUSIVITY EXPIRATION

APPL/PROD PATENT DATE REQUESTED DATE

NO PATENT NO CODES CODE(S)

DARUNAVIR ETHANOLATE - PREZISTA

N021976 006 >A> 5843946 Dec 01, 2015 DP U-1305 >A> D-129 Dec 13, 2013

>A> 5843946 Dec 01, 2015 DP U-744 >A> NPP Dec 16, 2014>A> PED Jun 16, 2015

>A> 5843946 Dec 01, 2015 DP U-903 >A> PED Jun 13, 2014>A> 5843946 Dec 01, 2015 DP U-935

>A> 5843946 Dec 01, 2015 DP U-1209

>A> 5843946*PED Jun 01, 2016

>A> 6037157 Jun 26, 2016 U-1305

>A> 6037157 Jun 26, 2016 U-935

>A> 6037157 Jun 26, 2016 U-1209

>A> 6037157*PED Dec 26, 2016

>A> 6248775 Aug 13, 2014 DS

>A> 6248775*PED Feb 13, 2015 U-1305

>A> 6335460 Aug 25, 2012 DS DP U-935

>A> 6335460 Aug 25, 2012 DS DP U-903

>A> 6335460 Aug 25, 2012 DS DP U-1209

>A> 6335460 Aug 25, 2012 DS DP U-1305

>A> 6335460 Aug 25, 2012 DS DP U-744

>A> 6335460*PED Feb 25, 2013

>A> 6703403 Jun 26, 2016 U-1209

>A> 6703403 Jun 26, 2016 U-1305

>A> 6703403 Jun 26, 2016 U-935

>A> 6703403*PED Dec 26, 2016

>A> 7470506 Jun 23, 2019 U-935

>A> 7470506 Jun 23, 2019 U-1209

>A> 7470506 Jun 23, 2019 U-1305

>A> 7470506*PED Dec 23, 2019

>A> 7700645 Dec 26, 2026 DS DP

>A> 7700645*PED Jun 26, 2027

>A> RE42889 Oct 19, 2016 DP

>A> RE42889*PED Apr 19, 2017

>A> RE43596 May 09, 2017 DS DP

>A> RE43596*PED Nov 09, 2017

>A> RE43802 Oct 19, 2016 U-1305

>A> RE43802*PED Apr 19, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 152: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 13

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

APPL/PRODNO PATENT NO

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

DARUNAVIR ETHANOLATE - PREZISTA

N202895 001 5843946>A>

5843946>A>

5843946*PED

6037157>A>

6037157>A>

6037157*PED

6248775

6248775*PED

6335460>A>

6335460>A>

6335460*PED

6703403>A>

6703403>A>

6703403*PED

7470506>A>

7470506*PED

7700645

7700645*PED

RE42889

RE42889*PED

RE43596

RE43596*PED

RE43802>A>

RE43802*PED >A>

Dec 01, 2015

Dec 01, 2015

Jun 01, 2016

Jun 26, 2016

Jun 26, 2016

Dec 26, 2016

Aug 13, 2014

Feb 13, 2015

Aug 25, 2012

Aug 25, 2012

Feb 25, 2013

Jun 26, 2016

Jun 26, 2016

Dec 26, 2016

Jun 23, 2019

Dec 23, 2019

Dec 26, 2026

Jun 26, 2027

Oct 19, 2016

Apr 19, 2017

May 09, 2017

Nov 09, 2017

Oct 19, 2016

Apr 19, 2017

DP U-1305

DP U-1209

U-1209

U-1305

DS

DS DP U-1209

DS DP U-1305

U-1305

U-1209

U-1209

DS DP

DP

DS DP

U-1305

U-1305

DEGARELIX ACETATE - FIRMAGON

N022201 001 5925730 May 18, 2021 DS DP U-943

DEGARELIX ACETATE - FIRMAGON

N022201 002 5925730 May 18, 2021 DS DP U-943

DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX-D 12 HOUR

N021313 001 8187630 Dec 19, 2020 DP U-1017

DESVENLAFAXINE SUCCINATE - PRISTIQ

N021992 001 8269040 Jul 05, 2027 DS

DESVENLAFAXINE SUCCINATE - PRISTIQ

N021992 002 8269040 Jul 05, 2027 DS

DEXAMETHASONE - OZURDEX

N022315 001 8088407 Oct 20, 2020 DP U-1205

DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST

N050818 001 8101582 Dec 19, 2027 DP U-1082

DEXLANSOPRAZOLE - DEXILANT

N022287 001 8105626

8105626*PED

8173158

8173158

8173158

8173158*PED

Sep 27, 2026

Mar 27, 2027

Mar 17, 2030

Mar 17, 2030

Mar 17, 2030

Sep 17, 2030

DP

U-951

U-950

U-949

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 153: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 14

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

DEXLANSOPRAZOLE - DEXILANT

N022287 002 8105626 Sep 27, 2026 DP

8105626*PED Mar 27, 2027

8173158 Mar 17, 2030 U-951

8173158 Mar 17, 2030 U-950

8173158 Mar 17, 2030 U-949

8173158*PED Sep 17, 2030

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE - NUEDEXTA

N021879 001 8227484 Jul 17, 2023 U-1093

DICLOFENAC POTASSIUM - CAMBIA

N022165 001 8097651 Jun 16, 2026 DS DP U-436

DICLOFENAC POTASSIUM - ZIPSOR

N022202 001 8110606 Feb 24, 2029 U-980

DICLOFENAC SODIUM - PENNSAID

N020947 001 8217078 Jul 10, 2029 U-1248

DIENOGEST; ESTRADIOL VALERATE - NATAZIA

N022252 001 8153616 Jan 30, 2028 U-1240 I-648

DIFLUPREDNATE - DUREZOL

N022212 001 I-653 ODE

DIPHENHYDRAMINE CITRATE; IBUPROFEN - ADVIL PM

N021394 001 8263647 May 30, 2022 DP

DORIPENEM - DORIBAX

N022106 001 8247402 Mar 30, 2021 DS DP

DORIPENEM - DORIBAX

N022106 002 8247402 Mar 30, 2021 DS DP

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE - COSOPT PF

N202667 001 NP

DOXYCYCLINE - ORACEA

N050805 001 8206740 Dec 24, 2025 DP U-925

DRONEDARONE HYDROCHLORIDE - MULTAQ

N022425 001 5223510 Jul 26, 2013 DS DP U-992

5223510 Jul 26, 2013 DS DP U-1261

DROSPIRENONE; ESTRADIOL - ANGELIQ

N021355 001 NS

EXCLUSIVITY EXPIRATION

DATE

Mar 14, 2015

Jun 13, 2015Jun 13, 2019

Feb 01, 2015

Mar 01, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 154: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 15

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

DULOXETINE HYDROCHLORIDE - CYMBALTA

PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N021427 001 5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269*PED

5508276

5508276*PED

6596756

6596756*PED

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Dec 11, 2013

Jul 18, 2014

Jan 18, 2015

Sep 10, 2019

Mar 10, 2020

DS DP U-882

DS DP U-839

DS DP U-799

DS DP U-797

DS DP U-796

DS DP U-795

DS DP U-605

DS DP U-398

DS DP U-1094

DP

U-882

I-632 I-617 PED PED

Nov Nov MayMay

04, 201319, 201204, 201419, 2013

DULOXETINE HYDROCHLORIDE - CYMBALTA

N021427 002 5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269*PED

5508276

5508276*PED

6596756

6596756*PED

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Dec 11, 2013

Jul 18, 2014

Jan 18, 2015

Sep 10, 2019

Mar 10, 2020

DS DP U-882

DS DP U-839

DS DP U-799

DS DP U-797

DS DP U-796

DS DP U-795

DS DP U-605

DS DP U-398

DS DP U-1094

DP

U-882

I-632 I-617 PED PED

Nov Nov MayMay

04, 201319, 201204, 201419, 2013

DULOXETINE HYDROCHLORIDE - CYMBALTA

N021427 004 5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269

5023269*PED

5508276

5508276*PED

6596756

6596756*PED

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Jun 11, 2013

Dec 11, 2013

Jul 18, 2014

Jan 18, 2015

Sep 10, 2019

Mar 10, 2020

DS DP U-882

DS DP U-839

DS DP U-799

DS DP U-797

DS DP U-796

DS DP U-795

DS DP U-605

DS DP U-398

DS DP U-1094

DP

U-882

I-632 I-617 PED PED

Nov Nov MayMay

04, 201319, 201204, 201419, 2013

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 155: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 16

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION DELIST EXCLUSIVITY EXPIRATION

APPL/PROD PATENT DATE REQUESTED DATE

NO PATENT NO CODES CODE(S)

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA

N021937 001 5663169 Sep 02, 2014 U-750

5663169 Sep 02, 2014 U-1170

5811423 Aug 07, 2012 U-750

5811423 Aug 07, 2012 U-1170

5922695 Jul 25, 2017 DS U-750

5922695 Jul 25, 2017 DS U-1170

5935946 Jul 25, 2017 DS DP U-750

5935946 Jul 25, 2017 DS DP U-1170

5977089 Jul 25, 2017 DS DP U-750

5977089 Jul 25, 2017 DS DP U-1170

6043230 Jul 25, 2017 U-750

6043230 Jul 25, 2017 U-1170

6642245 Nov 04, 2020 U-750

6642245 Nov 04, 2020 U-1170

ELTROMBOPAG OLAMINE - PROMACTA

N022291 001 >A> 6280959 Oct 30, 2018 DS DP U-930

>A> 6280959 Oct 30, 2018 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-930

>A> 7332481 May 24, 2021 U-1306

>A> 7332481 May 24, 2021 U-930

>A> 7473686 May 24, 2021 DS DP U-930

>A> 7473686 May 24, 2021 DS DP U-1306

>A> 7547719 Jul 13, 2025 DS DP U-930

>A> 7547719 Jul 13, 2025 DS DP U-1306

>A> 7790704 May 24, 2021 U-1306

>A> 7790704 May 24, 2021 U-930

>A> 7795293 May 21, 2023 U-1306

>A> 7795293 May 21, 2023 U-930

>A> 8052993 Aug 01, 2027 DP U-930

>A> 8052993 Aug 01, 2027 DP U-1306

ELTROMBOPAG OLAMINE - PROMACTA

N022291 002 >A> 6280959 Oct 30, 2018 DS DP U-930

>A> 6280959 Oct 30, 2018 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-930

>A> 7332481 May 24, 2021 U-1306

>A> 7332481 May 24, 2021 U-930

>A> 7473686 May 24, 2021 DS DP U-930

>A> 7473686 May 24, 2021 DS DP U-1306

>A> 7547719 Jul 13, 2025 DS DP U-930

>A> 7547719 Jul 13, 2025 DS DP U-1306

>A> 7790704 May 24, 2021 U-1306

>A> 7790704 May 24, 2021 U-930

>A> 7795293 May 21, 2023 U-1306

>A> 7795293 May 21, 2023 U-930

>A> 8052994 Aug 01, 2027 DP U-930

>A> 8052994 Aug 01, 2027 DP U-1306

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 156: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 17

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION DELIST EXCLUSIVITY EXPIRATION

APPL/PROD PATENT DATE REQUESTED DATE

NO PATENT NO CODES CODE(S)

ELTROMBOPAG OLAMINE - PROMACTA

N022291 003 >A> 6280959 Oct 30, 2018 DS DP U-930

>A> 6280959 Oct 30, 2018 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-930

>A> 7332481 May 24, 2021 U-1306

>A> 7332481 May 24, 2021 U-930

>A> 7473686 May 24, 2021 DS DP U-930

>A> 7473686 May 24, 2021 DS DP U-1306

>A> 7547719 Jul 13, 2025 DS DP U-930

>A> 7547719 Jul 13, 2025 DS DP U-1306

>A> 7790704 May 24, 2021 U-1306

>A> 7790704 May 24, 2021 U-930

>A> 7795293 May 21, 2023 U-1306

>A> 7795293 May 21, 2023 U-930

>A> 8062665 Aug 01, 2027 DP U-930

>A> 8062665 Aug 01, 2027 DP U-1306

ELTROMBOPAG OLAMINE - PROMACTA

N022291 004 >A> 6280959 Oct 30, 2018 DS DP U-930

>A> 6280959 Oct 30, 2018 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-930

>A> 7332481 May 24, 2021 U-1306

>A> 7332481 May 24, 2021 U-930

>A> 7473686 May 24, 2021 DS DP U-930

>A> 7473686 May 24, 2021 DS DP U-1306

>A> 7547719 Jul 13, 2025 DS DP U-930

>A> 7547719 Jul 13, 2025 DS DP U-1306

>A> 7790704 May 24, 2021 U-1306

>A> 7790704 May 24, 2021 U-930

>A> 7795293 May 21, 2023 U-1306

>A> 7795293 May 21, 2023 U-930

>A> 8071129 Aug 01, 2027 DP U-930

>A> 8071129 Aug 01, 2027 DP U-1306 DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 157: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 18

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED CODE(S) DATENO PATENT NO CODES

ELTROMBOPAG OLAMINE - PROMACTA

N022291 005 >A> 6280959 Oct 30, 2018 DS DP U-930 >A> NCE Nov 20, 2013

>A> 6280959 Oct 30, 2018 DS DP U-1306 >A> ODE Nov 20, 2015

>A> 7160870 Nov 20, 2022 DS DP U-1306

>A> 7160870 Nov 20, 2022 DS DP U-930

>A> 7332481 May 24, 2021 U-1306

>A> 7332481 May 24, 2021 U-930

>A> 7452874 May 24, 2021 DS DP

>A> 7473686 May 24, 2021 DS DP U-930

>A> 7473686 May 24, 2021 DS DP U-1306

>A> 7547719 Jul 13, 2025 DS DP U-1306

>A> 7547719 Jul 13, 2025 DS DP U-930

>A> 7790704 May 24, 2021 U-1306

>A> 7790704 May 24, 2021 U-930

>A> 7795293 May 21, 2023 U-1306

>A> 7795293 May 21, 2023 U-930

>A> 8052995 Aug 01, 2027 DP U-1306

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - COMPLERA

N202123 001 8080551 Apr 11, 2023 DS DP NCE May 20, 2016

8101629 Aug 09, 2022 DP

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - TRUVADA

N021752 001 5922695 Jul 25, 2017 DS U-1259

5922695 Jul 25, 2017 DS U-248

5922695 Jul 25, 2017 DS U-541

5922695 Jul 25, 2017 DS U-1170

5935946 Jul 25, 2017 DS DP U-541

5935946 Jul 25, 2017 DS DP U-1170

5935946 Jul 25, 2017 DS DP U-1259

5935946 Jul 25, 2017 DS DP U-248

5977089 Jul 25, 2017 DS DP U-1259

5977089 Jul 25, 2017 DS DP U-248

5977089 Jul 25, 2017 DS DP U-541

5977089 Jul 25, 2017 DS DP U-1170

6043230 Jul 25, 2017 DP U-541

6043230 Jul 25, 2017 DP U-1170

6043230 Jul 25, 2017 DP U-1259

6043230 Jul 25, 2017 DP U-248

ENTECAVIR - BARACLUDE

N021797 001 NPP Oct 12, 2015

ENTECAVIR - BARACLUDE

N021797 002 NPP Oct 12, 2015

ENTECAVIR - BARACLUDE

N021798 001 NPP Oct 12, 2015

ENZALUTAMIDE - XTANDI

N203415 001 7709517 Aug 13, 2027 DS DP NCE Aug 31, 2017

8183274 May 15, 2026 U-1281

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 158: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 19

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

EPINEPHRINE - AUVI-Q

N201739 001 8226610 Apr 10, 2029 DP

8231573 Nov 25, 2028 DP

EPROSARTAN MESYLATE - EPROSARTAN MESYLATE

A202012 001 PC Jun 17, 2012

EPROSARTAN MESYLATE - EPROSARTAN MESYLATE

A202012 002 PC Jun 17, 2012

ERIBULIN MESYLATE - HALAVEN

N201532 001 8097648 Jan 22, 2021 U-1096

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE

A076765 001 PC Sep 10, 2012

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE

A076765 002 PC Sep 10, 2012

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE

A076765 003 PC Sep 10, 2012

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N021957 001 5877192 May 27, 2014 U-773

5877192 May 27, 2014 U-729

5877192 May 27, 2014 U-1207

5877192*PED Nov 27, 2014

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N021957 002 5877192 May 27, 2014 U-773

5877192 May 27, 2014

5877192 May 27, 2014

U-729

U-1207

5877192*PED Nov 27, 2014

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N021957 003 5690960 Nov 25, 2014 DP U-1207

5690960*PED May 25, 2015

5714504 Feb 03, 2015 DP U-1207

5714504*PED Aug 03, 2015

5877192 May 27, 2014 U-1207

5877192*PED Nov 27, 2014

5900424 May 04, 2016

5900424*PED Nov 04, 2016

U-1207DS

6369085 May 25, 2018 DS DP U-1207

6369085*PED Nov 25, 2018

6428810 Nov 03, 2019 DP U-1207

6428810*PED May 03, 2020

6875872 May 27, 2014 DS

6875872*PED Nov 27, 2014

7411070 May 25, 2018 DS

7411070*PED Nov 25, 2018

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 159: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 20

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE CODES REQUESTED CODE(S) DATENO PATENT NO

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N021957 004 5690960 Nov 25, 2014 DP U-1207

5690960*PED May 25, 2015

5714504*PED Aug 03, 2015

5877192*PED Nov 27, 2014

5900424*PED Nov 04, 2016

6369085*PED Nov 25, 2018

6428810*PED May 03, 2020

6875872*PED Nov 27, 2014

7411070*PED Nov 25, 2018

5714504 Feb 03, 2015 DP U-1207

5877192 May 27, 2014 U-1207

5900424 May 04, 2016 DS U-1207

6369085 May 25, 2018 DS DP U-1207

6428810 Nov 03, 2019 DP U-1207

6875872 May 27, 2014 DS

7411070 May 25, 2018 DS

ESTRADIOL - MINIVELLE

N203752 001 >A> 6841716 Apr 27, 2020 DP

ESTRADIOL - MINIVELLE

N203752 002 >A> 6841716 Apr 27, 2020 DP

ESTRADIOL - MINIVELLE

N203752 003 >A> 6841716 Apr 27, 2020 DP

ESTRADIOL - MINIVELLE

N203752 004 >A> 6841716 Apr 27, 2020 DP

ESTRADIOL - VAGIFEM

N020908 002 >A> 5860946 Jul 01, 2017 DP

ESZOPICLONE - LUNESTA

N021476 001 6319926 Jan 16, 2012 U-620

6319926*PED Jul 16, 2012

6444673*PED Aug 14, 2014

6864257*PED Mar 02, 2013

7381724*PED Jul 16, 2012

6444673 Feb 14, 2014 DS DP

6864257 Aug 30, 2012 U-629

7381724 Jan 16, 2012 DS DP U-629

ESZOPICLONE - LUNESTA

N021476 002 6319926 Jan 16, 2012 U-620

6319926*PED Jul 16, 2012

6444673*PED Aug 14, 2014

6864257*PED Mar 02, 2013

7381724*PED Jul 16, 2012

6444673 Feb 14, 2014 DS DP

6864257 Aug 30, 2012 U-629

7381724 Jan 16, 2012 DS DP U-629

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 160: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 21

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

APPL/PRODNO PATENT NO

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

ESZOPICLONE - LUNESTA

N021476 003 6319926

6319926*PED

6444673

6444673*PED

6864257

6864257*PED

7381724

7381724*PED

Jan 16, 2012

Jul 16, 2012

Feb 14, 2014

Aug 14, 2014

Aug 30, 2012

Mar 02, 2013

Jan 16, 2012

Jul 16, 2012

U-620

DS DP

U-629

DS DP U-629

ETONOGESTREL - NEXPLANON

N021529 002

ETRAVIRINE - INTELENCE

NP May 31, 2014

N022187 001 6878717

6878717

6878717

7037917

7037917

7037917

Nov

Nov

Nov

Dec

Dec

Dec

05, 2019

05, 2019

05, 2019

13, 2020

13, 2020

13, 2020

U-256

U-1237

U-1016

DS DP U-256

DS DP U-1237

DS DP U-1016

NPP Mar 26, 2015

ETRAVIRINE - INTELENCE

N022187 002 6878717

6878717

6878717

7037917

7037917

7037917

Nov

Nov

Nov

Dec

Dec

Dec

05, 2019

05, 2019

05, 2019

13, 2020

13, 2020

13, 2020

U-256

U-1237

U-1016

DS DP U-256

DS DP U-1237

DS DP U-1016

NPP Mar 26, 2015

ETRAVIRINE - INTELENCE

N022187 003 6878717

6878717

6878717

7037917

7887845

8003789

Nov

Nov

Nov

Dec

Mar

Nov

05, 2019

05, 2019

05, 2019

13, 2020

25, 2019

01, 2019

U-256

U-1237

U-1016

DS DP U-1237

DP

DS DP

NPP NCE

Mar Jan

26, 201518, 2013

EVEROLIMUS - AFINITOR

N022334 001 5665772

5665772*PED

6004973

6004973*PED

7297703

7297703*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

Jun 06, 2020

DS DP

DP

DP

I-655 I-650 I-638 I-630 NCE ODE ODE ODE PED PED PED PED PED PED PED

Jul AprMayOct Mar AprMayOct Oct Nov AprOct Nov SepApr

20, 201526, 201505, 201429, 201330, 201426, 201905, 201829, 201726, 201905, 201829, 201826, 201505, 201430, 201429, 2014

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 161: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 22

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

EVEROLIMUS - AFINITOR

N022334 002 5665772

5665772*PED

6004973

6004973*PED

7297703

7297703*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

Jun 06, 2020

DS DP

DP

DP

I-655 I-650 I-638 I-630 NCE ODE ODE ODE PED PED PED PED PED PED PED

Jul AprMayOct Mar AprMayOct Oct Nov AprOct Nov SepApr

20, 201526, 201505, 201429, 201330, 201426, 201905, 201829, 201726, 201905, 201829, 201826, 201505, 201430, 201429, 2014

EVEROLIMUS - AFINITOR

N022334 003 5665772

5665772*PED

6004973

6004973*PED

7297703

7297703*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

Jun 06, 2020

DS DP

DP

DP

I-655 I-650 I-638 I-630 NCE ODE ODE ODE PED PED PED PED PED PED PED

Jul AprMayOct Mar AprMayOct Oct Nov AprOct Nov SepApr

20, 201526, 201505, 201429, 201330, 201426, 201905, 201829, 201726, 201905, 201829, 201826, 201505, 201430, 201429, 2014

EVEROLIMUS - AFINITOR

N022334 004 5665772

5665772*PED

6004973

6004973*PED

7297703

7297703*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

Jun 06, 2020

DS DP

DP

DP

I-655 I-650 I-638 I-630 NCE ODE ODE ODE PED PED PED PED PED PED PED

Jul AprMayOct Mar AprMayOct Oct Nov AprOct Nov SepApr

20, 201526, 201505, 201429, 201330, 201426, 201905, 201829, 201726, 201905, 201829, 201826, 201505, 201430, 201429, 2014

EVEROLIMUS - AFINITOR DISPERZ

N203985 001 5665772

5665772*PED

6004973

6004973*PED

7297703

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

DS DP

DP

DP

I-630 NCE ODE PED PED PED

Oct Mar Oct AprSepApr

29, 201330, 201429, 201729, 201830, 201429, 2014

7297703*PED Jun 06, 2020

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 162: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 23

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

APPL/PRODNO PATENT NO

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

EVEROLIMUS - AFINITOR DISPERZ

N203985 002 5665772

5665772*PED

6004973

6004973*PED

7297703

7297703*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

Jun 06, 2020

DS DP

DP

DP

I-630 NCE ODE PED PED PED

Oct Mar Oct AprSepApr

29, 201330, 201429, 201729, 201830, 201429, 2014

EVEROLIMUS - AFINITOR DISPERZ

N203985 003 5665772

5665772*PED

6004973

6004973*PED

7297703

7297703*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Dec 06, 2019

Jun 06, 2020

DS DP

DP

DP

I-630 NCE ODE PED PED PED

Oct Mar Oct AprSepApr

29, 201330, 201429, 201729, 201830, 201429, 2014

EVEROLIMUS - ZORTRESS

N021560 001 5665772

5665772*PED

6004973

6004973*PED

6239124

6239124*PED

6440990

6440990*PED

6455518

6455518*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Aug 11, 2017

Feb 11, 2018

Sep 24, 2013

Mar 24, 2014

Jul 29, 2017

Jan 29, 2018

DS DP U-1049

DP U-1049

U-1049

DP U-1049

U-1049

NP NCE PED PED

AprMar SepOct

20, 201330, 201430, 201420, 2013

EVEROLIMUS - ZORTRESS

N021560 002 5665772

5665772*PED

6004973

6004973*PED

6239124

6239124*PED

6440990

6440990*PED

6455518

6455518*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Aug 11, 2017

Feb 11, 2018

Sep 24, 2013

Mar 24, 2014

Jul 29, 2017

Jan 29, 2018

DS DP U-1049

DP U-1049

U-1049

DP U-1049

U-1049

NP NCE PED PED

AprMar SepOct

20, 201330, 201430, 201420, 2013

EVEROLIMUS - ZORTRESS

N021560 003 5665772

5665772*PED

6004973

6004973*PED

6239124

6239124*PED

6440990

6440990*PED

6455518

6455518*PED

Sep 09, 2019

Mar 09, 2020

Jul 12, 2016

Jan 12, 2017

Aug 11, 2017

Feb 11, 2018

Sep 24, 2013

Mar 24, 2014

Jul 29, 2017

Jan 29, 2018

DS DP U-1049

DP U-1049

U-1049

DP U-1049

U-1049

NP NCE PED PED

AprMar SepOct

20, 201330, 201430, 201420, 2013

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 163: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 24

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

EXENATIDE SYNTHETIC - BYDUREON

N022200 001 5424286 Dec 01, 2016 U-1108 NP Jan 27, 2015

6479065 Aug 10, 2020 DP

6495164 May 25, 2020 DP

6667061 May 25, 2020 DP

6824822 Oct 09, 2022 DP

6858576 Jan 06, 2017 U-656

6872700 Jan 14, 2020 U-654

6956026 Jan 07, 2018 U-687

7223440 Aug 31, 2021 DP

7456254 Jun 30, 2025 DP U-1223

7563871 Apr 15, 2024 DP

7612176 Apr 13, 2025 DP U-1223

7741269 Jan 07, 2018 U-1224

EXENATIDE SYNTHETIC - BYETTA

N021773 001 M-113 M-111

Oct Oct

19, 201419, 2014

EXENATIDE SYNTHETIC - BYETTA

N021773 002 M-113 M-111

Oct Oct

19, 201419, 2014

EZETIMIBE - ZETIA

N021445 001 M-109 Jan 24, 2015

EZETIMIBE; SIMVASTATIN - VYTORIN

N021687 001 M-109 Jan 24, 2015

EZETIMIBE; SIMVASTATIN - VYTORIN

N021687 002 M-109 Jan 24, 2015

EZETIMIBE; SIMVASTATIN - VYTORIN

N021687 003 M-109 Jan 24, 2015

EZETIMIBE; SIMVASTATIN - VYTORIN

N021687 004 M-109 Jan 24, 2015

FAMCICLOVIR - FAMVIR

N020363 001 M-112 Feb 09, 2015

FAMCICLOVIR - FAMVIR

N020363 002 M-112 Feb 09, 2015

FAMCICLOVIR - FAMVIR

N020363 003 M-112 Feb 09, 2015

FAMOTIDINE; IBUPROFEN - DUEXIS

N022519 001 8309127 Jul 18, 2026 DP

8318202>A> Jul 18, 2026 DP

FENOFIBRATE - FENOGLIDE

N022118 001 8124125 Oct 01, 2024 DP U-1234

FENOFIBRATE - FENOGLIDE

N022118 002 8124125 Oct 01, 2024 DP U-1234

FENTANYL - SUBSYS

N202788 001 NP Jan 04, 2015

FENTANYL - SUBSYS

N202788 002 NP Jan 04, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 164: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 25

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

FENTANYL - SUBSYS

N202788 003 NP Jan 04, 2015

FENTANYL - SUBSYS

N202788 004 NP Jan 04, 2015

FENTANYL - SUBSYS

N202788 005 NP Jan 04, 2015

FENTANYL CITRATE - FENTORA

N021947 001 8092832 Dec 30, 2024 DP

FENTANYL CITRATE - FENTORA

N021947 002 8092832 Dec 30, 2024 DP

8119158 Dec 30, 2024 DP

FENTANYL CITRATE - FENTORA

N021947 003 8092832 Dec 30, 2024 DP

8119158 Dec 30, 2024 DP

FENTANYL CITRATE - FENTORA

N021947 004 8092832 Dec 30, 2024 DP

8119158 Dec 30, 2024 DP

FENTANYL CITRATE - FENTORA

N021947 005 8092832 Dec 30, 2024 DP

8119158 Dec 30, 2024 DP

FENTANYL CITRATE - LAZANDA

N022569 001 8216604 Oct 03, 2024 U-767

FENTANYL CITRATE - LAZANDA

N022569 002 8216604 Oct 03, 2024 U-767

FENTANYL CITRATE - ONSOLIS

N022266 001 7579019 Jan 22, 2020 U-767

FENTANYL CITRATE - ONSOLIS

N022266 002 7579019 Jan 22, 2020 U-767

FENTANYL CITRATE - ONSOLIS

N022266 003 7579019 Jan 22, 2020 U-767

FENTANYL CITRATE - ONSOLIS

N022266 004 7579019 Jan 22, 2020 U-767

FENTANYL CITRATE - ONSOLIS

N022266 005 7579019 Jan 22, 2020 U-767

FESOTERODINE FUMARATE - TOVIAZ

N022030 001 6858650 Jul 03, 2022 DS U-913

8088398 Jun 07, 2027 DP U-913

FESOTERODINE FUMARATE - TOVIAZ

N022030 002 6858650 Jul 03, 2022 DS U-913

8088398 Jun 07, 2027 DP U-913

FINGOLIMOD - GILENYA

N022527 001 6004565 Sep 23, 2017 U-1086

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 165: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 26

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATENO PATENT NO CODES CODE(S)

FLORBETAPIR F-18 - AMYVID

N202008 001 7687052 Apr 30, 2027 DS DP NCE Apr 06, 2017

FLORBETAPIR F-18 - AMYVID

N202008 002 7687052 Apr 30, 2027 DS DP NCE Apr 06, 2017

FLORBETAPIR F-18 - AMYVID

N202008 003 7687052 Apr 30, 2027 DS DP NCE Apr 06, 2017

FLUNISOLIDE - AEROSPAN HFA

N021247 001 5776433 Jul 07, 2015 DP

5980867 Jul 06, 2018 DP

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - TRI-LUMA

N021112 001 8247395 Oct 22, 2022 DP

FLUOCINONIDE - VANOS

N021758 001 8232264 Mar 09, 2023 DP

FLUTICASONE FUROATE - VERAMYST

N022051 001 8062264 Apr 05, 2026 DP

8147461 Mar 10, 2025 DP

FLUTICASONE PROPIONATE - FLOVENT HFA

N021433 001 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

FLUTICASONE PROPIONATE - FLOVENT HFA

N021433 002 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

FLUTICASONE PROPIONATE - FLOVENT HFA

N021433 003 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

N021254 001 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

N021254 002 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

N021254 003 7832351 Jun 19, 2023 DP

7832351*PED Dec 19, 2023

FOSAMPRENAVIR CALCIUM - LEXIVA

N021548 001 NPP Apr 27, 2015PED Oct 27, 2015

FOSAMPRENAVIR CALCIUM - LEXIVA

N022116 001 NPP Apr 27, 2015PED Oct 27, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 166: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 27

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

FOSAPREPITANT DIMEGLUMINE - EMEND

N022023 002 5512570 Mar 04, 2014 U-850

5538982 Jul 23, 2013 U-850

5716942 Feb 10, 2015 U-850

7214692 Sep 18, 2012 U-850

FOSPROPOFOL DISODIUM - LUSEDRA

N022244 001 6204257 Jul 01, 2022 DS DP U-945

FULVESTRANT - FASLODEX

N021344 001 M-123 >A> Nov 09, 2015

GABAPENTIN - GRALISE

N022544 001 8192756 Oct 25, 2022 DP U-1114

8252332 Oct 25, 2022 DP U-1114

GABAPENTIN - GRALISE

N022544 002 8192756 Oct 25, 2022 DP U-1114

8252332 Oct 25, 2022 DP U-1114

GABAPENTIN ENACARBIL - HORIZANT

N022399 001 8048917 Nov 06, 2022 DS DP U-1247 I-652 Jun 06, 2015

8114909 Apr 11, 2026 U-1231

GABAPENTIN ENACARBIL - HORIZANT

N022399 002 8048917 Nov 06, 2022 DS DP U-1247 I-652 Jun 06, 2015

8114909 Apr 11, 2026 U-1231

GADOBENATE DIMEGLUMINE - MULTIHANCE

N021357 001 I-654 Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE

N021357 002 I-654 Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE

N021357 003 I-654 Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE

N021357 004 I-654 Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK

N021358 001 I-654 Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK

N021358 002 I-654 Jul 06, 2015

GADOFOSVESET TRISODIUM - ABLAVAR

N021711 001 6676929 May 04, 2020 DP

GADOFOSVESET TRISODIUM - ABLAVAR

N021711 002 6676929 May 04, 2020 DP

GADOXETATE DISODIUM - EOVIST

N022090 001 5798092 Aug 25, 2015 DS DP

6039931 Nov 13, 2021 U-1239

GLYCOPYRROLATE - CUVPOSA

N022571 001 ODE Jul 28, 2017

HYDROCHLOROTHIAZIDE; IRBESARTAN - IRBESARTAN AND HYDROCHLOROTHIAZIDE

A077369 001 PC Sep 26, 2012

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 167: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 28

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

EXCLUSIVITY CODE(S)

DELIST REQUESTED

EXPIRATION DATE

HYDROCHLOROTHIAZIDE; IRBESARTAN - IRBESARTAN AND HYDROCHLOROTHIAZIDE

A077369 002 PC Sep 26, 2012

HYDROCHLOROTHIAZIDE; VALSARTAN - VALSARTAN AND HYDROCHLOROTHIAZIDE

A078020 001 PC Mar 20, 2013

HYDROCHLOROTHIAZIDE; VALSARTAN - VALSARTAN AND HYDROCHLOROTHIAZIDE

A078020 002 PC Mar 20, 2013

HYDROCHLOROTHIAZIDE; VALSARTAN - VALSARTAN AND HYDROCHLOROTHIAZIDE

A078020 003 PC Mar 20, 2013

HYDROCHLOROTHIAZIDE; VALSARTAN - VALSARTAN AND HYDROCHLOROTHIAZIDE

A078020 004 PC Mar 20, 2013

HYDROCHLOROTHIAZIDE; VALSARTAN - VALSARTAN AND HYDROCHLOROTHIAZIDE

A078020 005 PC Mar 20, 2013

HYDROMORPHONE HYDROCHLORIDE - EXALGO

N021217 004 5702725 Jul 07, 2014 DP U-1043 NDF Mar 01, 2013

5914131 Jul 07, 2014 DP U-1043

ICOSAPENT ETHYL - VASCEPA

N202057 001 8188146 Jan 27, 2020 DS DP

8293727 Feb 09, 2030 U-1287

8293728 Feb 09, 2030 U-1287

8298554 Apr 29, 2030 DP

8314086 Feb 09, 2030 U-1287>A>

8318715 Feb 09, 2030 U-1287>A>

IMATINIB MESYLATE - GLEEVEC

N021588 001 ODE Dec 19, 2015

IMATINIB MESYLATE - GLEEVEC

N021588 002 ODE Dec 19, 2015

IMIQUIMOD - ZYCLARA

N022483 001 8236816 Dec 11, 2029 U-68

8299109 Dec 11, 2029 U-68

IMIQUIMOD - ZYCLARA

N022483 002 8222270 Dec 11, 2029 U-68

INGENOL MEBUTATE - PICATO

N202833 001 6432452 Aug 19, 2018 U-68DS NCE Jan 23, 2017

6844013 Aug 19, 2018 DS DP U-1221

7410656 Aug 19, 2018 U-1222DS

8278292 Feb 20, 2027 DS DP

INGENOL MEBUTATE - PICATO

N202833 002 6432452 Aug 19, 2018 U-68DS NCE Jan 23, 2017

6844013 Aug 19, 2018 DS DP U-1221

7410656 Aug 19, 2018 U-1222DS

8278292 Feb 20, 2027 DS DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30

N021172 001 5866538 Jun 19, 2017 DP

5866538*PED Dec 19, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 168: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 29

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION DELIST EXCLUSIVITY EXPIRATION

APPL/PROD PATENT DATE REQUESTED CODE(S) DATE

NO PATENT NO CODES

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 FLEXPEN

N021172 004 >A> 5547930 Sep 28, 2013 DS DP

>A> 5618913 Jun 07, 2014 DS DP

>A> 5618913*PED Dec 07, 2014

>A> 5834422 Sep 28, 2013 DP U-471

>A> 5840680 Sep 28, 2013 DS DP U-471

>A> 5866538 Jun 19, 2017 DP

>A> 5866538*PED Dec 19, 2017

>A> 6004297 Jan 28, 2019 DP

>A> 6235004 Jan 28, 2019 DP

>A> RE41956 Jan 21, 2021 DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL

N021172 002 >A> 5547930 Sep 28, 2013 DS DP

>A> 5618913 Jun 07, 2014 DS DP

>A> 5618913*PED Dec 07, 2014

>A> 5834422 Sep 28, 2013 DP U-471

>A> 5840680 Sep 28, 2013 DS DP U-471

>A> 5866538 Jun 19, 2017 DP

>A> 5866538*PED Dec 19, 2017

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL

N021172 003 >A> 5547930 Sep 28, 2013 DS DP

>A> 5618913 Jun 07, 2014 DS DP

>A> 5618913*PED Dec 07, 2014

>A> 5834422 Sep 28, 2013 DP U-471

>A> 5840680 Sep 28, 2013 DS DP U-471

>A> 5866538 Jun 19, 2017 DP

>A> 5866538*PED Dec 19, 2017

INSULIN ASPART RECOMBINANT - NOVOLOG FLEXPEN

N020986 003 >A> 5618913 Jun 07, 2014 DS DP

>A> 5618913*PED Dec 07, 2014

>A> 5866538 Jun 20, 2017 DP

>A> 5866538*PED Dec 20, 2017

>A> 6004297 Jan 28, 2019 DP

>A> 6004297*PED Jul 28, 2019

>A> 6235004 Jan 28, 2019 DP

>A> 6235004*PED Jul 28, 2019

>A> RE41956 Jan 21, 2021 DP

>A> RE41956*PED Jul 21, 2021

INSULIN ASPART RECOMBINANT - NOVOLOG INNOLET

N020986 004 >A> 5618913 Jun 07, 2014 DS DP

>A> 5618913*PED Dec 07, 2014

>A> 5866538 Jun 20, 2017 DP

>A> 5866538*PED Dec 20, 2017

>A> RE41956 Jan 21, 2021 DP

>A> RE41956*PED Jul 21, 2021

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 169: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 30

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

INSULIN ASPART RECOMBINANT - NOVOLOG PENFILL

N020986 002 5618913 Jun 07, 2014>A>

5618913*PED Dec 07, 2014>A>

5626566 May 06, 2014>A>

5626566*PED Nov 06, 2014>A>

5693027 Dec 02, 2014>A>

5693027*PED Jun 02, 2015>A>

5866538 Jun 20, 2017>A>

5866538*PED Dec 20, 2017>A>

PATENT CODES

DS DP

DP

DP

DP

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

INSULIN DETEMIR RECOMBINANT - LEVEMIR

N021536 001 5750497 Jun 16, 2019

INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXPEN

N021536 002 5750497 Jun 16, 2019>A>

5866538 Jun 20, 2017>A>

6004297 Jan 28, 2019>A>

6011007 Feb 02, 2014>A>

6235004 Jan 28, 2019>A>

6869930 Feb 02, 2014>A>

RE41956 Jan 21, 2021>A>

DS DP U-668

DS DP U-668

DS DP

DP

DS DP U-668

DP

DS DP U-668

DP

M-117 M-115

MayApr

18, 201506, 2015

INSULIN DETEMIR RECOMBINANT - LEVEMIR INNOLET

N021536 003 5750497 Jun 16, 2019>A>

5866538 Jun 20, 2017>A>

6011007 Feb 02, 2014>A>

6869930 Feb 02, 2014>A>

DS DP U-668

DS DP

DS DP U-668

DS DP U-668

INSULIN DETEMIR RECOMBINANT - LEVEMIR PENFILL

N021536 004 5750497 Jun 16, 2019>A>

5866538 Jun 20, 2017>A>

6011007 Feb 02, 2014>A>

6869930 Feb 02, 2014>A>

DS DP U-668

DS DP

DS DP U-668

DS DP U-668

INSULIN LISPRO RECOMBINANT - HUMALOG

N020563 001

INSULIN LISPRO RECOMBINANT - HUMALOG PEN

N020563 002

IOFLUPANE I-123 - DATSCAN

N022454 001 5310912 Feb 25, 2013 DS

NR

NR

Oct

Oct

12, 2015

12, 2015

IRBESARTAN - IRBESARTAN

A077159 001

IRBESARTAN - IRBESARTAN

A077159 002

IRBESARTAN - IRBESARTAN

A077159 003

IRON SUCROSE - VENOFER

N021135 001

IRON SUCROSE - VENOFER

N021135 002

PC

PC

PC

NPP

NPP

Sep

Sep

Sep

Sep

Sep

26, 2012

26, 2012

26, 2012

21, 2015

21, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 170: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 31

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATENO PATENT NO CODES CODE(S)

IRON SUCROSE - VENOFER

N021135 004 NPP Sep 21, 2015

ISOTRETINOIN - ABSORICA

N021951 001 7435427 Sep 21, 2021 DP NP May 25, 2015

ISOTRETINOIN - ABSORICA

N021951 002 7435427 Sep 21, 2021 DP NP May 25, 2015

ISOTRETINOIN - ABSORICA

N021951 003 7435427 Sep 21, 2021 DP NP May 25, 2015

ISOTRETINOIN - ABSORICA

N021951 004 7435427 Sep 21, 2021 DP NP May 25, 2015

IVACAFTOR - KALYDECO

N203188 001 7495103 May 20, 2027 DS DP NCE Jan 31, 2017ODE Jan 31, 2019

IVERMECTIN - SKLICE

N202736 001 6103248 May 22, 2018 DP NP Feb 07, 2015

IXABEPILONE - IXEMPRA KIT

N022065 001 RE41911 Sep 28, 2020 DS DP U-961

RE41911*PED Mar 28, 2021

IXABEPILONE - IXEMPRA KIT

N022065 002 RE41911 Sep 28, 2020 DS DP U-961

RE41911*PED Mar 28, 2021

KETOCONAZOLE - EXTINA

N021738 001 8026238 Oct 19, 2018 DP U-1213

KETOCONAZOLE - XOLEGEL

N021946 001 8232276 Nov 24, 2020 DP

KETOROLAC TROMETHAMINE - ACULAR LS

N021528 001 8008338*PED Nov 24, 2027

8207215 May 28, 2024 U-1251

8207215*PED Nov 28, 2024

LACOSAMIDE - VIMPAT

N022253 001 RE38551 Mar 17, 2022 DS DP U-914

LACOSAMIDE - VIMPAT

N022253 002 RE38551 Mar 17, 2022 DS DP U-914

LACOSAMIDE - VIMPAT

N022253 003 RE38551 Mar 17, 2022 DS DP U-914

LACOSAMIDE - VIMPAT

N022253 004 RE38551 Mar 17, 2022 DS DP U-914

LACOSAMIDE - VIMPAT

N022254 001 RE38551 Mar 17, 2022 DS DP U-911

LACOSAMIDE - VIMPAT

N022255 001 RE38551 Mar 17, 2022 DS DP U-914

LAMIVUDINE; ZIDOVUDINE - LAMIVUDINE AND ZIDOVUDINE

A079081 001 PC May 15, 2012

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 171: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 32

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION DELIST EXCLUSIVITY EXPIRATION

APPL/PROD PATENT DATE REQUESTED CODE(S) DATE

NO PATENT NO CODES

LENALIDOMIDE - REVLIMID

N021880 001 5635517 Oct 04, 2019 DS U-1211

6045501 Aug 28, 2018 U-1210

6281230 Jul 24, 2016 U-1212

6315720 Oct 23, 2020 U-1210

6555554 Jul 24, 2016 DP U-1211

6561976 Aug 28, 2018 U-1210

6561977 Oct 23, 2020 U-1210

6755784 Oct 23, 2020 U-1210

6908432 Aug 28, 2018 U-1210

7189740 Apr 11, 2023 U-1215

7465800 Apr 27, 2027 DS DP

7968569 Oct 07, 2023 U-1216

8204763 Aug 28, 2018 U-1249

8288415 Jul 24, 2016 DS DP

LENALIDOMIDE - REVLIMID

N021880 002 5635517 Oct 04, 2019 DS U-1211

6045501 Aug 28, 2018 U-1210

6281230 Jul 24, 2016 U-1212

6315720 Oct 23, 2020 U-1210

6555554 Jul 24, 2016 DP U-1211

6561976 Aug 28, 2018 U-1210

6561977 Oct 23, 2020 U-1210

6755784 Oct 23, 2020 U-1210

6908432 Aug 28, 2018 U-1210

7189740 Apr 11, 2023 U-1215

7465800 Apr 27, 2027 DS DP

7968569 Oct 07, 2023 U-1216

8204763 Aug 28, 2018 U-1249

8288415 Jul 24, 2016 DS DP

LENALIDOMIDE - REVLIMID

N021880 003 5635517 Oct 04, 2019 DS U-1211

6045501 Aug 28, 2018 U-1210

6281230 Jul 24, 2016 U-1212

6315720 Oct 23, 2020 U-1210

6555554 Jul 24, 2016 DP U-1211

6561976 Aug 28, 2018 U-1210

6561977 Oct 23, 2020 U-1210

6755784 Oct 23, 2020 U-1210

6908432 Aug 28, 2018 U-1210

7189740 Apr 11, 2023 U-1215

7465800 Apr 27, 2027 DS DP

7855217 Nov 24, 2024 DS DP

7968569 Oct 07, 2023 U-1216

8204763 Aug 28, 2018 U-1249

8288415 Jul 24, 2016 DS DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 172: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 33

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

EXCLUSIVITY CODE(S)

DELIST REQUESTED

EXPIRATION DATE

LENALIDOMIDE - REVLIMID

N021880 004 5635517 Oct 04, 2019 U-1211DS

6045501 Aug 28, 2018 U-1210

6281230 Jul 24, 2016 U-1212

6315720 Oct 23, 2020 U-1210

6555554 Jul 24, 2016 DP U-1211

6561976 Aug 28, 2018 U-1210

6561977 Oct 23, 2020 U-1210

6755784 Oct 23, 2020 U-1210

6908432 Aug 28, 2018 U-1210

7189740 Apr 11, 2023 U-1215

7465800 Apr 27, 2027 DS DP

7968569 Oct 07, 2023 U-1216

8204763 Aug 28, 2018 U-1249

8288415 Jul 24, 2016 DS DP

LENALIDOMIDE - REVLIMID

N021880 005 5635517 Oct 04, 2019 U-1211DS

6045501 Aug 28, 2018 U-1210

6281230 Jul 24, 2016 U-1212

6315720 Oct 23, 2020 U-1210

6555554 Jul 24, 2016 DP U-1211

6561976 Aug 28, 2018 U-1210

6561977 Oct 23, 2020 U-1210

6755784 Oct 23, 2020 U-1210

6908432 Aug 28, 2018 U-1210

7119106 Jul 24, 2016 DP

7189740 Apr 11, 2023 U-1215

7465800 Apr 27, 2027 DS DP

7855217 Nov 24, 2024 DS DP

7968569 Oct 07, 2023 U-1216

8204763 Aug 28, 2018 U-1249

8288415 Jul 24, 2016 DS DP

LEVETIRACETAM - KEPPRA

N021035 001 NPP PED

Dec 16, 2014Jun 16, 2015

LEVETIRACETAM - KEPPRA

N021035 002 NPP PED

Dec 16, 2014Jun 16, 2015

LEVETIRACETAM - KEPPRA

N021035 003 NPP PED

Dec 16, 2014Jun 16, 2015

LEVETIRACETAM - KEPPRA

N021035 004 NPP PED

Dec 16, 2014Jun 16, 2015

LEVETIRACETAM - KEPPRA

N021505 001 NPP PED

Dec 16, 2014Jun 16, 2015

LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL

N022064 001 5698558 Jul 26, 2013 U-812

5698558*PED Jan 26, 2014

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 173: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 34

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL

PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N022157 001 5698558

5698558*PED

Jul

Jan

26, 2013

26, 2014

U-852

LIDOCAINE; TETRACAINE - SYNERA

N021623 001 6465709 Jul 07, 2020 DP

LINACLOTIDE - LINZESS

N202811 001 7304036

7371727

7704947

7745409

8080526

8110553

Jan

Jan

Jan

Jan

Jan

Jan

28, 2024

28, 2024

28, 2024

28, 2024

28, 2024

28, 2024

DS DP U-1278

DS

DS DP

DS DP

DS DP

U-1278

NCE Aug 30, 2017

LINACLOTIDE - LINZESS

N202811 002 7304036

7371727

7704947

7745409

8080526

8110553

Jan

Jan

Jan

Jan

Jan

Jan

28, 2024

28, 2024

28, 2024

28, 2024

28, 2024

28, 2024

DS DP U-1278

DS

DS DP

DS DP

DS DP

U-1278

NCE Aug 30, 2017

LINAGLIPTIN - TRADJENTA

N201280 001 6303661

6303661

6890898

6890898

7078381

7078381

7459428

7459428

8119648

8119648

8178541

8178541

8178541

8178541

Apr 24, 2017

Apr 24, 2017

Feb 02, 2019

Feb 02, 2019

Feb 02, 2019

Feb 02, 2019

Feb 02, 2019

Feb 02, 2019

Aug 12, 2023

Aug 12, 2023

Aug 12, 2023

Aug 12, 2023

Aug 12, 2023

Aug 12, 2023

U-774

U-1270

U-493

U-1270

U-493

U-1270

U-493

U-1270

U-774

U-1270

U-775

U-1270

U-1245

U-1244

M-121 M-118

AugAug

13, 201513, 2015

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

N201281 001 6303661 Apr 24, 2017 U-802

6890898 Feb 02, 2019 U-1039

7078381 Feb 02, 2019 U-1039

7407955 Aug 12, 2023 DS DP

7459428 Feb 02, 2019 U-1039

8119648 Aug 12, 2023 U-802

8178541 Aug 12, 2023 DP U-775

NCE NC

MayJan

02, 201630, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 174: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 35

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

EXCLUSIVITY CODE(S)

DELIST REQUESTED

EXPIRATION DATE

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

N201281 002 6303661 Apr 24, 2017 U-802

6890898 Feb 02, 2019 U-1039

NCE NC

May 02, 2016Jan 30, 2015

7078381 Feb 02, 2019 U-1039

7407955 Aug 12, 2023 DS DP

7459428 Feb 02, 2019 U-1039

8119648 Aug 12, 2023 U-802

8178541 Aug 12, 2023 DP U-775

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

N201281 003 6303661 Apr 24, 2017 U-802

6890898 Feb 02, 2019 U-1039

NCE NC

May 02, 2016Jan 30, 2015

7078381 Feb 02, 2019 U-1039

7407955 Aug 12, 2023 DS DP

7459428 Feb 02, 2019 U-1039

8119648 Aug 12, 2023 U-802

8178541 Aug 12, 2023 DP U-775

LIRAGLUTIDE RECOMBINANT - VICTOZA

N022341 001 6004297 Jan 28, 2019 DP >A>

6235004 Jan 28, 2019 DP >A>

M-115 Apr 06, 2015

8114833 Aug 13, 2025 DP

RE41956 Jan 21, 2021 DP >A>

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 001 7662788 Feb 24, 2023 U-727 I-645 Jan 31, 2015

7713936 Feb 24, 2023 U-727

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 002 7662788 Feb 24, 2023 U-727 I-645 Jan 31, 2015

7713936 Feb 24, 2023 U-727

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 003 7662788 Feb 24, 2023 U-727 I-645 Jan 31, 2015

7713936 Feb 24, 2023 U-727

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 004 7662788 Feb 24, 2023 U-727 I-645 Jan 31, 2015

7671030 Feb 24, 2023 DP U-727

7674774 Mar 18, 2023 DP U-842

7678771 Mar 25, 2023 DP U-842

7687467 Apr 08, 2023 DP U-842

7713936 Feb 24, 2023 U-727

7718619 Feb 24, 2023 DP U-842

7723305 Feb 24, 2023 DP U-842

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 005 7662788 Feb 24, 2023 U-727 I-645 Jan 31, 2015

7713936 Feb 24, 2023 U-727

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 006 7662788 Feb 24, 2023 U-727 I-645 Jan 31, 2015

7713936 Feb 24, 2023 U-727

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 175: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 36

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO LOPINAVIR; RITONAVIR - KALETRA

N021906 001 8268349

8268349*PED

8309613>A>

8309613*PED >A>

PATENT EXPIRATION

DATE

Aug 25, 2024

Feb 25, 2025

Dec 24, 2024

Jun 24, 2025

PATENT CODES

DP

U-688

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

LOPINAVIR; RITONAVIR - KALETRA

N021906 002 8268349

8268349*PED

8309613>A>

8309613*PED >A>

Aug 25, 2024

Feb 25, 2025

Dec 24, 2024

Jun 24, 2025

DP

U-688

LORCASERIN HYDROCHLORIDE - BELVIQ

N022529 001 6953787 Apr 10, 2023

6953787 Apr 10, 2023

6953787 Apr 10, 2023

6953787 Apr 10, 2023

7514422 Apr 10, 2023

7514422 Apr 10, 2023

7514422 Apr 10, 2023

7514422 Apr 10, 2023

7977329 Apr 10, 2023

7977329 Apr 10, 2023

7977329 Apr 10, 2023

7977329 Apr 10, 2023

8168624 Apr 18, 2029

8207158 Apr 10, 2023

8207158 Apr 10, 2023

8207158 Apr 10, 2023

8207158 Apr 10, 2023

8273734 Apr 10, 2023

8273734 Apr 10, 2023

DS DP U-1253

DS DP U-1254

DS DP U-1255

DS DP U-1252

U-1252

U-1253

U-1254

U-1255

DS DP U-1254

DS DP U-1253

DS DP U-1255

DS DP U-1252

DS DP

U-1252

U-1253

U-1254

U-1255

U-1255

U-1254

NCE Jun 27, 2017

LOTEPREDNOL ETABONATE - LOTEMAX

N202872 001

LUBIPROSTONE - AMITIZA

NDF >A> Sep 28, 2015

N021908 001 8097649

8097653

8114890

Oct 16, 2020

Nov 14, 2022

Sep 05, 2020

DP

U-1214

DP

LUBIPROSTONE - AMITIZA

N021908 002 8097649

8114890

Oct 16, 2020

Sep 05, 2020

DP

DP

LUCINACTANT - SURFAXIN

N021746 001 5407914>A> Nov 17, 2013 DS DP U-1242

LURASIDONE HYDROCHLORIDE - LATUDA

N200603 001

LURASIDONE HYDROCHLORIDE - LATUDA

D-134 Apr 26, 2015

N200603 002

LURASIDONE HYDROCHLORIDE - LATUDA

D-134 Apr 26, 2015

N200603 003 5532372 Jul 02, 2013 DS D-134 NCE

AprOct

26, 201528, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 176: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 37

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED CODE(S) DATENO PATENT NO CODES

LURASIDONE HYDROCHLORIDE - LATUDA

N200603 004 5532372 Jul 02, 2013 DS D-134 Apr 26, 2015NCE Oct 28, 2015

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE - SUPREP BOWEL PREP KIT

N022372 001 >A> 6946149 Mar 07, 2023 DP U-837

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET

N021842 001 M-116 May 17, 2015

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET

N021842 002 M-116 May 17, 2015

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

A090406 001 PC Feb 13, 2013

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

A090406 002 PC Feb 13, 2013

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N021410 001 8236345 Oct 07, 2022 DP

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N021410 002 8236345 Oct 07, 2022 DP

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N021410 003 8236345 Oct 07, 2022 DP

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N021410 004 8236345 Oct 07, 2022 DP

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N021410 005 8236345 Oct 07, 2022 DP

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR

N202270 001 6303661 Apr 24, 2017 U-1227

6340475 Sep 19, 2016 DP

6635280 Sep 19, 2016 DP

6699871 Jul 26, 2022 DS DP U-1227

6890898 Feb 02, 2019 U-1228

7078381 Feb 02, 2019 U-1227

7125873 Jul 26, 2022 DP U-1227

7326708 Apr 11, 2026 DS DP U-1227

7459428 Feb 02, 2019 U-1227

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR

N202270 002 6303661 Apr 24, 2017 U-1227

6340475 Sep 19, 2016 DP

6635280 Sep 19, 2016 DP

6699871 Jul 26, 2022 DS DP U-1227

6890898 Feb 02, 2019 U-1228

7078381 Feb 02, 2019 U-1227

7125873 Jul 26, 2022 DP U-1227

7326708

7459428

Apr 11, 2026

Feb 02, 2019

DS DP U-1227

U-1227

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 177: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 38

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR

N202270 003 6303661 Apr 24, 2017 U-1227

6340475 Sep 19, 2016 DP

6635280 Sep 19, 2016 DP

6699871 Jul 26, 2022 DS DP U-1227

6890898 Feb 02, 2019 U-1228

7078381 Feb 02, 2019 U-1227

7125873 Jul 26, 2022 DP U-1227

7326708 Apr 11, 2026 DS DP U-1227

7459428 Feb 02, 2019 U-1227

METHYLNALTREXONE BROMIDE - RELISTOR

N021964 001 8247425 Dec 31, 2030 U-1185

METHYLNALTREXONE BROMIDE - RELISTOR

N021964 002 8247425 Dec 31, 2030 U-1185

METHYLNALTREXONE BROMIDE - RELISTOR

N021964 003 8247425 Dec 31, 2030 U-1185

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 001 8163798 Jul 31, 2017 DP

8163798*PED Jan 31, 2018

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 002 8163798 Jul 31, 2017 DP

8163798*PED Jan 31, 2018

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 003 8163798 Jul 31, 2017 DP

8163798*PED Jan 31, 2018

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 004 8163798 Jul 31, 2017 DP

8163798*PED Jan 31, 2018

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE

A078458 001 PC Jul 01, 2012

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE

A078458 002 PC Jul 01, 2012

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE

A078458 003 PC Jul 01, 2012

METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR

N202100 001 NDF Aug 27, 2015

MICONAZOLE - ORAVIG

N022404 001 7651698 Sep 11, 2022 U-1051

MIFEPRISTONE - KORLYM

N202107 001 >A>

NP ODE

Feb Feb

17, 201517, 2019

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 001 6602911 Jan 14, 2023 U-882

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 002 6602911 Jan 14, 2023 U-882

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 178: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 39

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 003 6602911 Jan 14, 2023 U-882

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 004 6602911 Jan 14, 2023 U-882

MINOCYCLINE HYDROCHLORIDE - ARESTIN

N050781 001 6682348 Mar 29, 2022 DP

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 001 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 002 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 003 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 004 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 005 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 006 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 007 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 008 8252776 Jun 24, 2025 U-124

8268804 Jun 24, 2025 U-1078

MIRABEGRON - MYRBETRIQ

N202611 001 6346532 Oct 15, 2018 DS DP NCE Jun 28, 2017

6562375 Aug 01, 2020 DP

6699503

7342117

Sep 10, 2013

Nov 04, 2023

DP

DS

7750029 Dec 18, 2023 U-913

7982049 Nov 04, 2023 DP

MIRABEGRON - MYRBETRIQ

N202611 002 6346532 Oct 15, 2018 DS DP NCE Jun 28, 2017

6562375 Aug 01, 2020 DP

6699503 Sep 10, 2013 DP

7342117 Nov 04, 2023 DS

7750029 Dec 18, 2023 U-913

7982049 Nov 04, 2023 DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 179: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 40

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

MITOMYCIN - MITOSOL

N022572 001 7806265 Feb 01, 2029 DP ODE Feb 07, 2019

8186511 Jul 19, 2026 DP

MOMETASONE FUROATE - ASMANEX TWISTHALER

N021067 001 8173172 Mar 17, 2018 DP

8173172*PED Sep 17, 2018

MOMETASONE FUROATE - ASMANEX TWISTHALER

N021067 002 8173172 Mar 17, 2018 DP

8173172*PED Sep 17, 2018

MONTELUKAST SODIUM - SINGULAIR

N020829 002 NPP Mar 26, 2015

MONTELUKAST SODIUM - SINGULAIR

N020830 001 NPP Mar 26, 2015

MONTELUKAST SODIUM - SINGULAIR

N020830 002 NPP Mar 26, 2015

MONTELUKAST SODIUM - SINGULAIR

N021409 001 NPP Mar 26, 2015

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 001 7682633 Jun 19, 2027 U-1241

8158156 Jun 19, 2027 U-1241

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 002 7682633 Jun 19, 2027 U-1241

8158156 Jun 19, 2027 U-1241

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 003 7682633 Jun 19, 2027 U-1241

8158156 Jun 19, 2027 U-1241

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 004 7682633 Jun 19, 2027 U-1241

8158156 Jun 19, 2027 U-1241

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 005 7682633 Jun 19, 2027 U-1241

8158156 Jun 19, 2027 U-1241

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 006 7682633 Jun 19, 2027 U-1241

8158156 Jun 19, 2027 U-1241

NAFTIFINE HYDROCHLORIDE - NAFTIN

N019599 002 NS Jan 13, 2015

NEPAFENAC - NEPAFENAC

N203491 001 NP Oct 16, 2015

NEVIRAPINE - VIRAMUNE XR

N201152 001 >A> NPP Nov 08, 2015

NEVIRAPINE - VIRAMUNE XR

N201152 002 >A> >A>

NPP NDF

Nov Mar

08, 201525, 2014

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 180: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 41

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO NICOTINE - NICODERM CQ

N020165 004 8075911

PATENT EXPIRATION

DATE

May 22, 2021

PATENT CODES

DP

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

NICOTINE - NICODERM CQ

N020165 005 8075911 May 22, 2021 DP

NICOTINE - NICODERM CQ

N020165 006 8075911 May 22, 2021 DP

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA

N022068 001 8163904 Aug 23, 2028 DS DP

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA

N022068 002 8163904 Aug 23, 2028 DS DP

NITRIC OXIDE - INOMAX

N020845 002 5558083

5558083*PED

5732693

5732693*PED

5752504

5752504*PED

8282966

8282966*PED

8291904

8291904*PED

8293284

8293284*PED

Nov 22, 2013

May 22, 2014

Dec 13, 2016

Jun 13, 2017

Dec 13, 2016

Jun 13, 2017

Jun 30, 2029

Dec 30, 2029

Jan 06, 2031

Jul 06, 2031

Jun 30, 2029

Dec 30, 2029

DP U-1226

DP U-1230

DP U-1230

U-1286

DP U-1226

U-1286

NITRIC OXIDE - INOMAX

N020845 003 5558083

5558083*PED

5732693

5732693*PED

5752504

5752504*PED

8282966

8282966*PED

8291904

8291904*PED

8293284

8293284*PED

Nov 22, 2013

May 22, 2014

Dec 13, 2016

Jun 13, 2017

Dec 13, 2016

Jun 13, 2017

Jun 30, 2029

Dec 30, 2029

Jan 06, 2031

Jul 06, 2031

Jun 30, 2029

Dec 30, 2029

DP U-1226

DP U-1230

DP U-1230

U-1286

DP U-1226

U-1286

NITROGLYCERIN - NITROLINGUAL PUMPSPRAY

N018705 002 7872049 Mar 14, 2028 DP U-39

OMACETAXINE MEPESUCCINATE - SYNRIBO

N203585 001 6987103>A>

7842687>A>

Jun

Mar

28, 2023

16, 2019

U-1300

DS DP U-1299

NCE ODE >A>

Oct Oct

26, 201726, 2019

OXCARBAZEPINE - OXTELLAR XR

N202810 001 7722898>A>

7910131>A>

Apr 13, 2027

Apr 13, 2027

DP

U-1298

NDF >A> Oct 19, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 181: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 42

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

OXCARBAZEPINE - OXTELLAR XR

N202810 002 7722898 Apr 13, 2027>A>

7910131 Apr 13, 2027>A>

DP

U-1298

NDF >A> Oct 19, 2015

OXCARBAZEPINE - OXTELLAR XR

N202810 003 7722898 Apr 13, 2027>A>

7910131 Apr 13, 2027>A>

DP

U-1298

NDF >A> Oct 19, 2015

OXCARBAZEPINE - TRILEPTAL

N021285 001 8119148 Dec 19, 2020 DP U-724

8119148*PED Jun 19, 2021

OXYBUTYNIN - ANTUROL

N202513 001 7029694 Apr 26, 2020 DP U-318

7179483 Apr 26, 2020 U-318

7198801 Jun 25, 2022 DP

8241662 Apr 26, 2020 U-318

OXYBUTYNIN CHLORIDE - GELNIQUE

N022204 001 8241662 Apr 26, 2020 U-318

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 001 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 002 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 003 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 004 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 005 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 006 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N022272 007 8114383 Oct 10, 2024 DP

8309060 Nov 20, 2023 DP U-443

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 001 7851482 Jul 10, 2029 DS

8114383 Aug 08, 2024 DP

8192722 Sep 15, 2025 DP

8309060 Nov 20, 2023 DP

8309122 Feb 04, 2023 DP

8329216 Feb 04, 2023>A> DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 182: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 43

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 002 7851482 Jul 10, 2029 DS

8114383 Aug 08, 2024 DP

8192722 Sep 15, 2025 DP

8309060 Nov 20, 2023 DP

8309122 Feb 04, 2023 DP

8329216>A> Feb 04, 2023 DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 003 7851482 Jul 10, 2029 DS

8114383 Aug 08, 2024 DP

8192722

8309060

Sep 15, 2025

Nov 20, 2023

DP

DP

8309122 Feb 04, 2023 DP

8329216>A> Feb 04, 2023 DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 004 7851482 Jul 10, 2029 DS

8114383 Aug 08, 2024 DP

8192722 Sep 15, 2025 DP

8309060 Nov 20, 2023 DP

8309122 Feb 04, 2023 DP

8329216>A> Feb 04, 2023 DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 005 7851482 Jul 10, 2029 DS

8114383

8192722

Aug 08, 2024

Sep 15, 2025

DP

DP

8309060 Nov 20, 2023 DP

8309122 Feb 04, 2023 DP

8329216>A> Feb 04, 2023 DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 006 7851482 Jul 10, 2029 DS

8114383 Aug 08, 2024 DP

8192722 Sep 15, 2025 DP

8309060 Nov 20, 2023 DP

8309122 Feb 04, 2023 DP

8329216>A> Feb 04, 2023 DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 007 7851482 Jul 10, 2029 DS

8114383 Aug 08, 2024 DP

8192722 Sep 15, 2025 DP

8309060 Nov 20, 2023 DP

8309122 Feb 04, 2023 DP

8329216>A> Feb 04, 2023 DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 183: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 44

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION DELIST EXCLUSIVITY EXPIRATION

APPL/PROD PATENT DATE REQUESTED CODE(S) DATE

NO PATENT NO CODES

PACLITAXEL - ABRAXANE

N021660 001 5439686 Feb 22, 2013 DP U-1290 I-658 Oct 11, 2015

5439686 Feb 22, 2013 DP U-1092

5498421 Mar 12, 2013 DP U-1092

5498421 Mar 12, 2013 DP U-1290

5498421 Mar 12, 2013 DP U-634

6096331 Feb 22, 2013 DP U-1092

6096331 Feb 22, 2013 DP U-1290

6096331 Feb 22, 2013 DP U-633

6506405 Feb 22, 2013 DP U-1092

6506405 Feb 22, 2013 DP U-1290

6506405 Feb 22, 2013 DP U-633

6537579 Feb 22, 2013 U-632

6537579 Feb 22, 2013 U-1290

6537579 Feb 22, 2013 U-1092

7820788 Mar 03, 2024 DP U-1092

7820788 Mar 03, 2024 DP U-1290

7923536 Dec 09, 2023 U-1117

7923536 Dec 09, 2023 U-1290

8034375 Aug 13, 2026 U-1290

8138229 Dec 09, 2023 DP U-1092

8138229 Dec 09, 2023 DP U-1290

8268348 Feb 21, 2026 U-1290

>A> 8314156 Dec 09, 2023 U-1290

RE41884 Aug 14, 2016 U-1290

RE41884 Aug 14, 2016 U-1117

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N022264 001 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015

5254556*PED Apr 15, 2014

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N022264 002 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015

5254556*PED Apr 15, 2014

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N022264 003 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015

5254556*PED Apr 15, 2014

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N022264 004 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015

5254556*PED Apr 15, 2014

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N022264 005 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015

5254556*PED Apr 15, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON

N020725 004 I-625 Apr 30, 2013M-93 Jul 29, 2019NCE Apr 30, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE

N022175 001 NCE May 17, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 184: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 45

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE

N022175 002

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ULTRESA

N022222 001

PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

NCE

NCE

EXCLUSIVITY EXPIRATION

DATE

May 17, 2017

Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ULTRESA

N022222 002 NCE Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ULTRESA

N022222 003 NCE Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - VIOKACE

N022542 001 NCE Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - VIOKACE

N022542 002 NCE Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 001 8221747 Feb 20, 2028

8246950 Feb 20, 2028

DP

U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 002 8221747 Feb 20, 2028

8246950 Feb 20, 2028

DP

U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 003 8221747 Feb 20, 2028

8246950 Feb 20, 2028

DP

U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 004 8221747 Feb 20, 2028

8246950 Feb 20, 2028

DP

U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 005 8221747 Feb 20, 2028 DP NCE Aug 27, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 006 8221747 Feb 20, 2028 DP NCE Aug 27, 2014

PAZOPANIB HYDROCHLORIDE - VOTRIENT

N022465 001 7105530>A>

8114885

Oct

Dec

19, 2023

19, 2021

DS DP

DS DP

I-649 ODE

AprApr

26, 201526, 2019

PAZOPANIB HYDROCHLORIDE - VOTRIENT

N022465 002 7105530>A>

8114885

Oct

Dec

19, 2023

19, 2021

DS DP

DS DP

I-649 ODE

AprApr

26, 201526, 2019

PEGINESATIDE ACETATE - OMONTYS

N202799 007 7084245

7414105

7528104

7550433

7919118

7919461

May 12, 2024

May 12, 2024

May 12, 2024

Jun 02, 2026

May 12, 2024

Jun 02, 2026

DS DP U-1238

DS DP U-1238

DS DP

U-1238

DS DP

U-1238

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 185: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 46

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

PEGINESATIDE ACETATE - OMONTYS

N202799 008 7084245 May 12, 2024 DS DP U-1238

7414105 May 12, 2024 DS DP U-1238

7528104 May 12, 2024 DS DP

7550433 Jun 02, 2026 U-1238

7919118 May 12, 2024 DS DP

7919461 Jun 02, 2026 U-1238

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N202799 001 7084245 May 12, 2024 DS DP U-1238 NCE

7414105 May 12, 2024 DS DP U-1238

7528104

7550433

May 12, 2024

Jun 02, 2026

DS DP

U-1238

7919118 May 12, 2024 DS DP

7919461 Jun 02, 2026 U-1238

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N202799 002 7084245 May 12, 2024 DS DP U-1238 NCE

7414105 May 12, 2024 DS DP U-1238

7528104 May 12, 2024 DS DP

7550433 Jun 02, 2026 U-1238

7919118 May 12, 2024 DS DP

7919461 Jun 02, 2026 U-1238

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N202799 003 7084245 May 12, 2024 DS DP U-1238 NCE

7414105

7528104

May 12, 2024

May 12, 2024

DS DP U-1238

DS DP

7550433 Jun 02, 2026 U-1238

7919118 May 12, 2024 DS DP

7919461 Jun 02, 2026 U-1238

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N202799 004 7084245 May 12, 2024 DS DP U-1238 NCE

7414105 May 12, 2024 DS DP U-1238

7528104 May 12, 2024 DS DP

7550433 Jun 02, 2026 U-1238

7919118

7919461

May 12, 2024

Jun 02, 2026

DS DP

U-1238

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N202799 005 7084245 May 12, 2024 DS DP U-1238 NCE

7414105 May 12, 2024 DS DP U-1238

7528104 May 12, 2024 DS DP

7550433 Jun 02, 2026 U-1238

7919118 May 12, 2024 DS DP

7919461 Jun 02, 2026 U-1238

EXCLUSIVITY EXPIRATION

DATE

Mar 27, 2017

Mar 27, 2017

Mar 27, 2017

Mar 27, 2017

Mar 27, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 186: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 47

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N202799 006 7084245

7414105

7528104

7550433

7919118

7919461

May 12, 2024

May 12, 2024

May 12, 2024

Jun 02, 2026

May 12, 2024

Jun 02, 2026

DS DP U-1238

DS DP U-1238

DS DP

U-1238

DS DP

U-1238

NCE Mar 27, 2017

PEMETREXED DISODIUM - ALIMTA

N021462 001 7772209>A>

7772209>A>

7772209*PED >A>

Nov 24, 2021

Nov 24, 2021

May 24, 2022

U-1296

U-1077

M-122 Oct 17, 2015

PEMETREXED DISODIUM - ALIMTA

N021462 002 7772209>A>

7772209*PED >A>

Nov 24, 2021

May 24, 2022

U-1296 M-122 Oct 17, 2015

PERAMPANEL - FYCOMPA

N202834 001 6949571>A> Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017

PERAMPANEL - FYCOMPA

N202834 002 6949571>A> Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017

PERAMPANEL - FYCOMPA

N202834 003 6949571>A> Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017

PERAMPANEL - FYCOMPA

N202834 004 6949571>A> Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017

PERAMPANEL - FYCOMPA

N202834 005 6949571>A> Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017

PERAMPANEL - FYCOMPA

N202834 006 6949571>A> Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017

PHENTERMINE HYDROCHLORIDE - SUPRENZA

N202088 003 6149938 Jul 23, 2018 DP U-1243

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N022580 001 7056890 Jun 14, 2020

7553818 Jun 14, 2020

7659256 Jun 14, 2020

7674776 Jun 14, 2020

DP U-1262

U-1262

DP U-1262

DP U-1262

NC Jul 17, 2015

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N022580 002 7056890 Jun 14, 2020

7553818 Jun 14, 2020

7659256 Jun 14, 2020

7674776 Jun 14, 2020

DP U-1262

U-1262

DP U-1262

DP U-1262

NC Jul 17, 2015

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N022580 003 7056890 Jun 14, 2020

7553818 Jun 14, 2020

7659256 Jun 14, 2020

7674776 Jun 14, 2020

DP U-1262

U-1262

DP U-1262

DP U-1262

NC Jul 17, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 187: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 48

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED CODE(S) DATENO PATENT NO CODES

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N022580 004 7056890 Jun 14, 2020 DP U-1262 NC Jul 17, 2015

7553818 Jun 14, 2020 U-1262

7659256 Jun 14, 2020 DP U-1262

7674776 Jun 14, 2020 DP U-1262

PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE

A076801 001 PC Feb 13, 2013

PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE

A076801 002 PC Feb 13, 2013

PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE

A076801 003 PC Feb 13, 2013

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 001 8133883 Apr 14, 2023 DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 002 8133883 Apr 14, 2023 DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 003 8133883 Apr 14, 2023 DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 004 8133883 Apr 14, 2023 DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER

N050750 001 8133883 Apr 14, 2023 DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER

N050750 002 8133883 Apr 14, 2023 DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER

N050750 003 8133883 Apr 14, 2023 DP U-282

POSACONAZOLE - NOXAFIL

N022003 001 8263600 Apr 01, 2022 DP

PREDNISOLONE ACETATE - FLO-PRED

N022067 001 7799331 Oct 11, 2028 DP U-139

7799331 Oct 11, 2028 DP U-1068

PREDNISOLONE ACETATE - FLO-PRED

N022067 002 7799331 Oct 11, 2028 DP U-139

7799331 Oct 11, 2028 DP U-1068

PREDNISONE - RAYOS

N202020 001 6488960 Mar 14, 2020 DP U-1267

6677326 Mar 14, 2020 DP U-1268

8309124 Apr 23, 2024 U-1292

PREDNISONE - RAYOS

N202020 002 6488960 Mar 14, 2020 DP U-1267

6677326 Mar 14, 2020 DP U-1268

8309124 Apr 23, 2024

PREDNISONE - RAYOS

N202020 003 8168218 Jan 07, 2028 DP U-1269

8309124 Apr 23, 2024 U-1292

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 188: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 49

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED CODE(S) DATENO PATENT NO CODES

PREGABALIN - LYRICA

N021446 001 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 002 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 003 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 004 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 005 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 006 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 007 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N021446 008 6001876 Dec 30, 2018 U-819 Y I-651 Jun 20, 2015

6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PREGABALIN - LYRICA

N022488 001 6001876 Dec 30, 2018 U-819 Y 6001876 Dec 30, 2018 U-55 Y RE41920 Dec 30, 2018 U-1250

PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL

N021438 001 6500454 Oct 04, 2021 DP

PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL

N021438 002 6500454 Oct 04, 2021 DP

RABEPRAZOLE SODIUM - ACIPHEX

N020973 001 >A>

>A>

5045552

5045552*PED

May 08, 2013

Nov 08, 2013

U-385

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 189: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 50

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO RABEPRAZOLE SODIUM - ACIPHEX

N020973 002 5045552>A>

5045552*PED >A>

PATENT EXPIRATION

DATE

May 08, 2013

Nov 08, 2013

PATENT CODES

U-385

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

RALTEGRAVIR POTASSIUM - ISENTRESS

N022145 001 M-114 Mar 28, 2015

RALTEGRAVIR POTASSIUM - ISENTRESS

N203045 001 7169780

7217713

7435734

7754731

Oct

Oct

Oct

Mar

03, 2023

21, 2022

21, 2022

11, 2029

DS DP

U-257

U-257

DS DP U-257

M-114 Mar 28, 2015

RALTEGRAVIR POTASSIUM - ISENTRESS

N203045 002 7169780

7217713

7435734

7754731

Oct

Oct

Oct

Mar

03, 2023

21, 2022

21, 2022

11, 2029

DS DP

U-257

U-257

DS DP U-257

M-114 Mar 28, 2015

REGADENOSON - LEXISCAN

N022161 001 8106029

8106183

8133879

8183226

Jun

Feb

Jun

Jun

22, 2019

02, 2027

22, 2019

22, 2019

U-1042

DS

DP

U-116

REGORAFENIB - STIVARGA

N203085 001 7351834 Jan 12, 2020 DS NCE Sep 27, 2017

REPAGLINIDE - PRANDIN

N020741 001 6677358 Jun 12, 2018 DS DP U-1265

REPAGLINIDE - PRANDIN

N020741 002 6677358 Jun 12, 2018 DS DP U-1265

REPAGLINIDE - PRANDIN

N020741 003 6677358 Jun 12, 2018 DS DP U-1265

RETAPAMULIN - ALTABAX

N022055 001 RE43390 Apr 12, 2021 DS DP U-805

RIFAXIMIN - XIFAXAN

N021361 001 8158644

8158781

8193196

Jun 19, 2024

Jun 19, 2024

Sep 02, 2027

DP

DS

DS DP

RIFAXIMIN - XIFAXAN

N022554 001 8158644

8158781

8193196

Jun 19, 2024

Jun 19, 2024

Sep 02, 2027

DP

DS

DS DP

RILPIVIRINE HYDROCHLORIDE - EDURANT

N202022 001 8080551

8101629

Apr 11, 2023

Aug 09, 2022

DS DP

DP

RISEDRONATE SODIUM - ATELVIA

N022560 001 8246989 Jan 16, 2026 DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 190: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 51

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATENO PATENT NO CODES CODE(S)

RITONAVIR - NORVIR

N022417 001 8268349 Aug 25, 2024 DP

8268349*PED Feb 25, 2925

RIVAROXABAN - XARELTO

N022406 001 >A> 7592339 Dec 11, 2020 U-1303 >A> I-662 Nov 02, 2015

>A> 7592339 Dec 11, 2020 U-1302 >A> I-661 Nov 02, 2015>A> I-660 Nov 02, 2015

>A> 7592339 Dec 11, 2020 U-1301

>A> 7592339 Dec 11, 2020 U-1200

>A> 7592339 Dec 11, 2020 U-1167

RIVAROXABAN - XARELTO

N022406 002 >A> 7592339 Dec 11, 2020 U-1303 >A> I-662 Nov 02, 2015

>A> 7592339 Dec 11, 2020 U-1302 >A> I-661 Nov 02, 2015>A> I-660 Nov 02, 2015

>A> 7592339 Dec 11, 2020 U-1301 >A> NCE Jul 01, 2016>A> 7592339 Dec 11, 2020 U-1200

>A> 7592339 Dec 11, 2020 U-1167

RIVAROXABAN - XARELTO

N022406 003 >A> 7592339 Dec 11, 2020 U-1303 >A> I-662 Nov 02, 2015

>A> 7592339 Dec 11, 2020 U-1302 >A> I-661 Nov 02, 2015>A> I-660 Nov 02, 2015

>A> 7592339 Dec 11, 2020 U-1301

>A> 7592339 Dec 11, 2020 U-1200

>A> 7592339 Dec 11, 2020 U-1167

RIVAROXABAN - XARELTO

N202439 001 >A> 7157456 Feb 08, 2021 DS DP U-1302

>A> 7157456 Feb 08, 2021 DS DP U-1301

>A> 7592339 Dec 11, 2020 U-1303

>A> 7592339 Dec 11, 2020 U-1302

>A> 7592339 Dec 11, 2020 U-1301

>A> 7592339 Dec 11, 2020 U-1200

>A> 7592339 Dec 11, 2020 U-1167

RIVAROXABAN - XARELTO

N202439 002 >A> 7157456 Feb 08, 2021 DS DP U-1302

>A> 7157456 Feb 08, 2021 DS DP U-1301

>A> 7592339 Dec 11, 2020 U-1303

>A> 7592339 Dec 11, 2020 U-1302

>A> 7592339 Dec 11, 2020 U-1301

>A> 7592339 Dec 11, 2020 U-1200

>A> 7592339 Dec 11, 2020 U-1167

RIVASTIGMINE - EXELON

N022083 005 5602176 Feb 11, 2014 DS DP U-322 NS Aug 31, 2015

6316023 Jan 08, 2019 DP

6335031 Jan 08, 2019 DP

RIZATRIPTAN BENZOATE - MAXALT

N020864 001 5602162 Jan 28, 2012 Y 5602162*PED Jul 28, 2012

RIZATRIPTAN BENZOATE - MAXALT

N020864 002 5602162 Jan 28, 2012 Y 5602162*PED Jul 28, 2012

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 191: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 52

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATENO PATENT NO CODES CODE(S)

RIZATRIPTAN BENZOATE - MAXALT-MLT

N020865 001 5602162 Jan 28, 2012 U-240 Y 5602162*PED Jul 28, 2012

RIZATRIPTAN BENZOATE - MAXALT-MLT

N020865 002 5602162 Jan 28, 2012 U-240 Y 5602162*PED Jul 28, 2012

ROMIDEPSIN - ISTODAX

N022393 001 4977138 Aug 22, 2013 DS DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 001 >A> 8303986 Apr 12, 2021 DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 002 >A> 8303986 Apr 12, 2021 DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 003 >A> 8303986 Apr 12, 2021 DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 004 >A> 8303986 Apr 12, 2021 DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 005 >A> 8303986 Apr 12, 2021 DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 006 >A> 8303986 Apr 12, 2021 DP

ROTIGOTINE - NEUPRO

N021829 001 8246979 Sep 01, 2027 DP U-1273 I-647 Apr 02, 2015

8246979 Sep 01, 2027 DP U-1272 I-646 Apr 02, 2015

8246980 Nov 27, 2025 DP

ROTIGOTINE - NEUPRO

N021829 002 8246979 Sep 01, 2027 DP U-1273 I-647 Apr 02, 2015

8246979 Sep 01, 2027 DP U-1272 I-646 Apr 02, 2015

8246980 Nov 27, 2025 DP

ROTIGOTINE - NEUPRO

N021829 003 8246979 Sep 01, 2027 DP U-1273 I-647 Apr 02, 2015

8246979 Sep 01, 2027 DP U-1272 I-646 Apr 02, 2015

8246980 Nov 27, 2025 DP

ROTIGOTINE - NEUPRO

N021829 004 6699498 Nov 27, 2020 DP I-647 Apr 02, 2015

6884434 Mar 30, 2021 DP I-646 Apr 02, 2015

7413747 Mar 18, 2019 DP

8246979 Sep 01, 2027 DP U-1273

8246979 Sep 01, 2027 DP U-1272

8246980 Nov 27, 2025 DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 192: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 53

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED DATENO PATENT NO CODES CODE(S)

ROTIGOTINE - NEUPRO

N021829 005 6699498 Nov 27, 2020 DP I-647 Apr 02, 2015

6884434 Mar 30, 2021 DP I-646 Apr 02, 2015

7413747 Mar 18, 2019 DP

8246979 Sep 01, 2027 DP U-1273

8246979 Sep 01, 2027 DP U-1272

8246980 Nov 27, 2025 DP

ROTIGOTINE - NEUPRO

N021829 006 6699498 Nov 27, 2020 DP I-647 Apr 02, 2015

6884434 Mar 30, 2021 DP I-646 Apr 02, 2015

7413747 Mar 18, 2019 DP

8246979 Sep 01, 2027 DP U-1273

8246979 Sep 01, 2027 DP U-1272

8246980 Nov 27, 2025 DP

RUFINAMIDE - BANZEL

N021911 001 7750028 Oct 19, 2018 U-106

RUFINAMIDE - BANZEL

N021911 002 7750028 Oct 19, 2018 U-106

RUFINAMIDE - BANZEL

N021911 003 7750028 Oct 19, 2018 U-106

RUFINAMIDE - BANZEL

N201367 001 6740669 Nov 14, 2022 DS DP

7750028 Oct 19, 2018 U-106

SAPROPTERIN DIHYDROCHLORIDE - KUVAN

N022181 001 >A> RE43797 Nov 17, 2024 U-1156

SILDENAFIL CITRATE - REVATIO

N021845 001 5250534 Mar 27, 2012 DS DP I-598 May 07, 2012

5250534*PED Sep 27, 2012 M-61 Aug 30, 2015PED Mar 01, 2016PED Nov 07, 2012

SILDENAFIL CITRATE - REVATIO

N022473 001 5250534 Mar 27, 2012 DS DP M-61 Aug 30, 2015

5250534*PED Sep 27, 2012 NDF Nov 20, 2012PED Mar 01, 2016PED May 20, 2013

SILDENAFIL CITRATE - REVATIO

N203109 001 NDF Aug 30, 2015PED Mar 01, 2016

SILDENAFIL CITRATE - VIAGRA

N020895 001 5250534 Mar 27, 2012

5250534*PED Sep 27, 2012

6469012 Oct 22, 2019 U-155

6469012*PED Apr 22, 2020

SILDENAFIL CITRATE - VIAGRA

N020895 002 5250534 Mar 27, 2012

5250534*PED Sep 27, 2012

6469012 Oct 22, 2019 U-155

6469012*PED Apr 22, 2020

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 193: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 54

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT EXPIRATION

APPL/PROD DATENO PATENT NO

SILDENAFIL CITRATE - VIAGRA

N020895 003 5250534 Mar 27, 2012

5250534*PED Sep 27, 2012

6469012 Oct 22, 2019

6469012*PED Apr 22, 2020

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 001 6699871 Jul 26, 2022

8168637 Jun 26, 2022

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 002 6699871 Jul 26, 2022

8168637 Jun 26, 2022

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 003 6699871 Jul 26, 2022

8168637 Jun 26, 2022

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 004 6303661 Apr 24, 2017

6699871 Jul 26, 2022

6890898 Feb 02, 2019

6890898 Feb 02, 2019

6890898 Feb 02, 2019

7078381 Feb 02, 2019

7125873 Jul 26, 2022

7125873 Jul 26, 2022

7125873 Jul 26, 2022

7125873 Jul 26, 2022

7326708 Apr 11, 2026

7459428 Feb 02, 2019

8168637 Jun 26, 2022

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 005 6303661 Apr 24, 2017

6699871 Jul 26, 2022

6890898 Feb 02, 2019

6890898 Feb 02, 2019

6890898 Feb 02, 2019

7078381 Feb 02, 2019

7125873 Jul 26, 2022

7125873 Jul 26, 2022

7125873 Jul 26, 2022

7125873 Jul 26, 2022

7326708 Apr 11, 2026

7459428 Feb 02, 2019

8168637 Jun 26, 2022

PATENT EXCLUSIVITY PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

U-155

DS DP U-1188

DP U-1188

DS DP U-1188

DP U-1188

DS DP U-1188

DP U-1188

U-1188

DS DP U-1188

U-1191

U-1190

U-1189

U-1188

DP U-1193

DP U-1192

DP U-1190

DP U-1189

DS DP U-1188

U-1189

DP U-1188

U-1188

DS DP U-1188

U-1191

U-1190

U-1189

U-1188

DP U-1193

DP U-1192

DP U-1190

DP U-1189

DS DP U-1188

U-1189

DP U-1188

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 194: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 55

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

PATENT NOAPPL/PROD

NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 006 6303661 Apr 24, 2017 U-1188

6699871 Jul 26, 2022 DS DP U-1188

6890898 Feb 02, 2019 U-1191

6890898 Feb 02, 2019 U-1190

6890898 Feb 02, 2019 U-1189

7078381 Feb 02, 2019 U-1188

7125873 Jul 26, 2022 DP U-1193

7125873 Jul 26, 2022 DP U-1192

7125873 Jul 26, 2022 DP U-1190

7125873 Jul 26, 2022 DP U-1189

7326708 Apr 11, 2026 DS DP U-1188

7459428 Feb 02, 2019 U-1189

8168637 Jun 26, 2022 DP U-1188

SODIUM NITRITE - SODIUM NITRITE

N203922 001 ODE Jan 14, 2018

SODIUM OXYBATE - XYREM

N021196 001 8263650 Dec 22, 2019 DP U-1102

8263650 Dec 22, 2019 DP U-1101

8324275 Dec 22, 2019>A> U-1102

8324275 Dec 22, 2019>A> U-1101

SODIUM THIOSULFATE - SODIUM THIOSULFATE

N203923 001 ODE Jan 14, 2018

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N021148 008 6716198 Jun 05, 2021>A> DP

6899699 Jan 02, 2022>A> DP

7686786 Aug 03, 2026>A> DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N021148 009 6716198 Jun 05, 2021>A> DP

6899699 Jan 02, 2022>A> DP

7686786 Aug 03, 2026>A> DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N021148 010 6716198 Jun 05, 2021>A> DP

6899699 Jan 02, 2022>A> DP

7686786 Aug 03, 2026>A> DP

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 004 6004297 Jan 28, 2019>A> DP

6235004 Jan 28, 2019>A> DP

RE41956 Jan 21, 2021>A> DP

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 005 6004297 Jan 28, 2019>A> DP

6235004 Jan 28, 2019>A> DP

RE41956 Jan 21, 2021>A> DP

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 006 6004297 Jan 28, 2019>A> DP

6235004 Jan 28, 2019>A> DP

RE41956 Jan 21, 2021>A> DP

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 195: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 56

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N021148 007 6004297>A>

6235004>A>

RE41956>A>

Jan

Jan

Jan

28, 2019

28, 2019

21, 2021

DP

DP

DP

SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO

N022239 001 7776007

8118771

8241243

8241244

8267903

8287489>A>

Nov 22, 2026

Aug 10, 2023

Dec 25, 2025

Nov 21, 2022

Mar 18, 2023

Dec 06, 2024

DP

DP

DP

DP

DP

DP

TAFLUPROST - ZIOPTAN

N202514 001 5886035 Dec 18, 2017 DS DP U-778 NCE Feb 10, 2017

TALIGLUCERASE ALFA - ELELYSO

N022458 001 8227230 Feb 24, 2024 DS DP NCE May 01, 2017

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N203794 001 6071970

7994364

RE39593

Jun 06, 2017

Jun 27, 2025

Aug 05, 2022

U-1289

DS DP U-1289

DS DP U-1289

NCE Nov 20, 2013

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 001 6071970

6071970

7994364

7994364

8114383

8309060>A>

RE39593

RE39593

Jun 06, 2017

Jun 06, 2017

Jun 27, 2025

Jun 27, 2025

Oct 10, 2024

Nov 20, 2023

Aug 05, 2022

Aug 05, 2022

U-1276

U-1178

DS DP U-1276

DS DP U-1178

DP

DP U-1178

DS DP U-1276

DS DP U-1178

I-656 Aug 28, 2015

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 002 6071970

6071970

7994364

7994364

8114383

8309060>A>

RE39593

RE39593

Jun 06, 2017

Jun 06, 2017

Jun 27, 2025

Jun 27, 2025

Oct 10, 2024

Nov 20, 2023

Aug 05, 2022

Aug 05, 2022

U-1276

U-1178

DS DP U-1276

DS DP U-1178

DP

DP U-1178

DS DP U-1276

DS DP U-1178

I-656 Aug 28, 2015

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 003 6071970

6071970

7994364

7994364

8114383

8309060>A>

RE39593

RE39593

Jun 06, 2017

Jun 06, 2017

Jun 27, 2025

Jun 27, 2025

Oct 10, 2024

Nov 20, 2023

Aug 05, 2022

Aug 05, 2022

U-1276

U-1178

DS DP U-1276

DS DP U-1178

DP

DP U-1178

DS DP U-1276

DS DP U-1178

I-656 Aug 28, 2015

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 196: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 57

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

APPL/PRODNO PATENT NO

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 004 6071970

6071970

7994364

7994364

8114383

8309060>A>

RE39593

RE39593

Jun 06, 2017

Jun 06, 2017

Jun 27, 2025

Jun 27, 2025

Oct 10, 2024

Nov 20, 2023

Aug 05, 2022

Aug 05, 2022

U-1276

U-1178

DS DP U-1276

DS DP U-1178

DP

DP U-1178

DS DP U-1276

DS DP U-1178

I-656 Aug 28, 2015

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 005 6071970

6071970

7994364

7994364

8114383

8309060>A>

RE39593

RE39593

Jun 06, 2017

Jun 06, 2017

Jun 27, 2025

Jun 27, 2025

Oct 10, 2024

Nov 20, 2023

Aug 05, 2022

Aug 05, 2022

U-1276

U-1178

DS DP U-1276

DS DP U-1178

DP

DP U-1178

DS DP U-1276

DS DP U-1178

I-656 Aug 28, 2015

TAZAROTENE - FABIOR

N202428 001 NDF May 11, 2015

TECHNETIUM TC-99M SULFUR COLLOID KIT - AN-SULFUR COLLOID

N017858 001 ODE Aug 13, 2019

TELAVANCIN HYDROCHLORIDE - VIBATIV

N022110 001 8101575

8158580

May 01, 2021

May 01, 2021

DP

DP

TELAVANCIN HYDROCHLORIDE - VIBATIV

N022110 002 8101575

8158580

May 01, 2021

May 01, 2021

DP

DP

TELBIVUDINE - TYZEKA

N022154 001 7858594 Sep 11, 2023 DS DP U-999

TEMSIROLIMUS - TORISEL

N022088 001 5362718

5362718*PED

8026276

8026276*PED

8299116>A>

8299116*PED >A>

Apr 18, 2014

Oct 18, 2014

Jan 20, 2026

Jul 20, 2026

Jul 25, 2023

Jan 25, 2024

DS DP

DP

DP

M-92 M-91 M-61 ODE PED PED PED PED

Jul AprMayMayNov Nov Jan Oct

09, 201326, 201330, 201530, 201430, 201530, 201409, 201426, 2013

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 197: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 58

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO

PATENT EXPIRATION

DATE

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N021356 001 5922695

5922695

5922695

5922695

5922695

5977089

5977089

5977089

5977089

5977089

6043230

6043230

6043230

6043230

6043230

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

Jul

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

U-999DS

U-256DS

U-250DS

U-248DS

U-1275DS

DS DP U-999

DS DP U-256

DS DP U-250

DS DP U-248

DS DP U-1275

U-999

U-256

U-250

U-248

U-1275

NPP NPP PED

AugJan Jul

16, 201518, 201518, 2015

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N021356 002 5922695

5922695

5922695

5922695

5922695

5922695*PED

5935946

5935946

5935946

5935946

5935946*PED

5977089

5977089

5977089

5977089

5977089

5977089*PED

6043230

6043230

6043230

6043230

6043230

6043230*PED

Jul

Jul

Jul

Jul

Jul

Jan

Jul

Jul

Jul

Jul

Jan

Jul

Jul

Jul

Jul

Jul

Jan

Jul

Jul

Jul

Jul

Jul

Jan

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2018

25, 2017

25, 2017

25, 2017

25, 2017

25, 2018

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2018

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2018

U-248DS

U-250DS

U-256DS

U-999DS

U-1275DS

DS DP U-248

DS DP U-250

DS DP U-256

DS DP U-999

DS DP U-248

DS DP U-250

DS DP U-256

DS DP U-999

DS DP U-1275

U-1275

U-248

U-250

U-256

U-999

M-95 NPP NPP NPP ODE PED PED PED PED

Oct AugJan Mar Mar SepJul AprSep

01, 201316, 201518, 201524, 201324, 201724, 201718, 201501, 201424, 2013

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 198: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 59

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

APPL/PROD DATE REQUESTED CODE(S) DATENO PATENT NO CODES

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N021356 003 5922695 Jul 25, 2017 DS U-248 M-95 Oct 01, 2013

5922695 Jul 25, 2017 DS U-250 NPP Aug 16, 2015NPP Jan 18, 2015

5922695 Jul 25, 2017 DS U-256 NPP Mar 24, 20135922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017 5922695 Jul 25, 2017 DS U-1275 PED Sep 24, 2017

PED Jul 18, 20155922695*PED Jan 25, 2018 PED Apr 01, 20145935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2013 5935946 Jul 25, 2017 DS DP U-250

5935946 Jul 25, 2017 DS DP U-256

5935946 Jul 25, 2017 DS DP U-999

5935946*PED Jan 25, 2018

5977089 Jul 25, 2017 DS DP U-248

5977089 Jul 25, 2017 DS DP U-250

5977089 Jul 25, 2017 DS DP U-256

5977089 Jul 25, 2017 DS DP U-999

5977089 Jul 25, 2017 DS DP U-1275

5977089*PED Jan 25, 2018

6043230 Jul 25, 2017 U-1275

6043230 Jul 25, 2017 U-248

6043230 Jul 25, 2017 U-250

6043230 Jul 25, 2017 U-256

6043230 Jul 25, 2017 U-999

6043230*PED Jan 25, 2018

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N021356 004 5922695 Jul 25, 2017 DS U-248 M-95 Oct 01, 2013

5922695 Jul 25, 2017 DS U-250 NPP Aug 16, 2015NPP Jan 18, 2015

5922695 Jul 25, 2017 DS U-256 NPP Mar 24, 20135922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017 5922695 Jul 25, 2017 DS U-1275 PED Sep 24, 2017

PED Jul 18, 20155922695*PED Jan 25, 2018 PED Apr 01, 20145935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2013 5935946 Jul 25, 2017 DS DP U-250

5935946 Jul 25, 2017 DS DP U-256

5935946 Jul 25, 2017 DS DP U-999

5935946*PED Jan 25, 2018

5977089 Jul 25, 2017 DS DP U-248

5977089 Jul 25, 2017 DS DP U-250

5977089 Jul 25, 2017 DS DP U-256

5977089 Jul 25, 2017 DS DP U-999

5977089 Jul 25, 2017 DS DP U-1275

5977089*PED Jan 25, 2018

6043230 Jul 25, 2017 U-1275

6043230 Jul 25, 2017 U-248

6043230 Jul 25, 2017 U-250

6043230 Jul 25, 2017 U-256

6043230 Jul 25, 2017 U-999

6043230*PED Jan 25, 2018

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 199: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 60

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N022577 001 5922695

5922695

5922695

5922695

5922695

5922695*PED

5935946

5935946

Jul

Jul

Jul

Jul

Jul

Jan

Jul

Jul

25, 2017

25, 2017

25, 2017

25, 2017

25, 2017

25, 2018

25, 2017

25, 2017

U-248DS

U-250DS

U-256DS

U-999DS

U-1275DS

DS DP U-999

DS DP U-1275

M-95 NPP NPP NDF ODE PED PED PED PED

Oct AugMar Jan Mar SepJul AprSep

01, 201316, 201524, 201318, 201524, 201724, 201718, 201501, 201424, 2013

5935946 Jul 25, 2017 DS DP U-248

5935946 Jul 25, 2017 DS DP U-250

5935946 Jul 25, 2017 DS DP U-256

5935946*PED Jan 25, 2018

5977089 Jul 25, 2017 DS DP U-248

5977089 Jul 25, 2017 DS DP U-250

5977089 Jul 25, 2017 DS DP U-256

5977089 Jul 25, 2017 DS DP U-999

5977089 Jul 25, 2017 DS DP U-1275

5977089*PED Jan 25, 2018

6043230 Jul 25, 2017 U-1275

6043230 Jul 25, 2017 U-248

6043230 Jul 25, 2017 U-250

6043230 Jul 25, 2017 U-256

6043230 Jul 25, 2017 U-999

6043230*PED Jan 25, 2018

TERIFLUNOMIDE - AUBAGIO

N202992 001 5459163

5679709

Oct

Oct

17, 2012

21, 2014

DP

DP U-1285

NCE Sep 12, 2017

TERIFLUNOMIDE - AUBAGIO

N202992 002 5459163

5679709

Oct

Oct

17, 2012

21, 2014

DP

DP U-1285

NCE Sep 12, 2017

TESAMORELIN ACETATE - EGRIFTA

N022505 002 5861379 May 26, 2015 DS DP U-1100 NCE Nov 10, 2015

6020311 May 26, 2015 DS DP U-1100

7144577 Jul 14, 2020 U-1100

7316997 Aug 14, 2023 U-1100

TESTOSTERONE - ANDROGEL

N022309 002 NP Apr 29, 2014

TESTOSTERONE - ANDROGEL

N022309 003 NP Apr 29, 2014

TESTOSTERONE - TESTIM

N021454 001 8178518 Apr 21, 2023 DP

TESTOSTERONE - TESTOSTERONE

N202763 001 NP Feb 14, 2015

THALIDOMIDE - THALOMID

N020785 001 8143283 Mar 01, 2013 U-1236

8204763 Aug 28, 2018 U-1249

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 200: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 61

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

THALIDOMIDE - THALOMID

N020785 002 8143283 Mar 01, 2013 U-1236

8204763 Aug 28, 2018 U-1249

THALIDOMIDE - THALOMID

N020785 003 8143283 Mar 01, 2013 U-1236

8204763 Aug 28, 2018 U-1249

THALIDOMIDE - THALOMID

N020785 004 8143283 Mar 01, 2013 U-1236

8204763 Aug 28, 2018 U-1249

TOFACITINIB CITRATE - XELJANZ

N203214 001 >A> 6956041 Dec 08, 2020 DP >A> NCE Nov 06, 2017

>A> 6965027 Mar 25, 2023 DS

>A> 7091208 Dec 08, 2020 U-247

>A> 7265221 Dec 08, 2020 DS

>A>

>A>

7301023

RE41783

May 23, 2022

Dec 08, 2020

DS

DS

TOLVAPTAN - SAMSCA

N022275 001 5258510 Nov 02, 2012 DS DP

TOLVAPTAN - SAMSCA

N022275 002 5258510 Nov 02, 2012 DS DP

TOLVAPTAN - SAMSCA

N022275 003 5258510 Nov 02, 2012 DS DP

TOPIRAMATE - TOPAMAX

N020505 001 NPP Jul 15, 2014

TOPIRAMATE - TOPAMAX

N020505 002 NPP Jul 15, 2014

TOPIRAMATE - TOPAMAX

N020505 004 NPP Jul 15, 2014

TOPIRAMATE - TOPAMAX

N020505 005 NPP Jul 15, 2014

TOPIRAMATE - TOPAMAX

N020844 001 NPP Jul 15, 2014

TOPIRAMATE - TOPAMAX

N020844 002 NPP Jul 15, 2014

TOPOTECAN HYDROCHLORIDE - HYCAMTIN

N020981 001 8158645 Dec 10, 2024 DP

TOPOTECAN HYDROCHLORIDE - HYCAMTIN

N020981 002 8158645 Dec 10, 2024 DP

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE

A091607 001 PC Jun 27, 2012

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE

A091607 002 PC Jun 27, 2012

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE

A091607 003 PC Jun 27, 2012

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 201: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 62

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT NOAPPL/PROD

NO TRANEXAMIC ACID - LYSTEDA

PATENT EXPIRATION

DATE PATENT CODES

PATENT DELIST

REQUESTED EXCLUSIVITY

CODE(S)

EXCLUSIVITY EXPIRATION

DATE

N022430 001 8273795 Mar 04, 2025 U-1182

TRAVOPROST - TRAVATAN Z

N021994 001 8268299 Oct 13, 2029 DP

TRAZODONE HYDROCHLORIDE - OLEPTRO

N022411 001 8133893 Mar 13, 2029 DS DP

TRAZODONE HYDROCHLORIDE - OLEPTRO

N022411 002 8133893 Mar 13, 2029 DS DP

TRIAMCINOLONE ACETONIDE - TRIESENCE

N022048 001 8128960

8211880

8211880

Dec

Mar

Mar

17, 2029

10, 2029

10, 2029

DP

U-1258

U-1257

TRYPAN BLUE - MEMBRANEBLUE

N022278 001 ODE Feb 20, 2016

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 001 8273876 Jul 23, 2027 U-1288

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 002 8273876 Jul 23, 2027 U-1288

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 003 8273876 Jul 23, 2027 U-1288

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 004 8273876 Jul 23, 2027 U-1288

VEMURAFENIB - ZELBORAF

N202429 001 8143271 Jun 21, 2026 DS DP

VILAZODONE HYDROCHLORIDE - VIIBRYD

N022567 001 8193195

8236804

Jun

Jun

05, 2022

05, 2022

U-839

U-839

VILAZODONE HYDROCHLORIDE - VIIBRYD

N022567 002 8193195

8236804

Jun

Jun

05, 2022

05, 2022

U-839

U-839

VILAZODONE HYDROCHLORIDE - VIIBRYD

N022567 003 8193195

8236804

Jun

Jun

05, 2022

05, 2022

U-839

U-839

VINCRISTINE SULFATE - MARQIBO KIT

N202497 001 5543152 Jun 20, 2014

5741516 Jun 20, 2014

5814335 Jun 20, 2014

6723338 Mar 31, 2020

7247316 Sep 25, 2020

7887836 Mar 31, 2020

DP

DP

DP

U-1271

DP

U-1271

NP ODE

AugAug

09, 201509, 2019

VISMODEGIB - ERIVEDGE

N203388 001 7888364 Nov 11, 2028 DS DP NCE Jan 30, 2017

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 202: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

A - 63 PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 11 - November 2012

See List footnote for information regarding List content

PATENT PATENT EXCLUSIVITY

APPL/PRODNO PATENT NO

EXPIRATION DATE

PATENT CODES

DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXPIRATION DATE

VORINOSTAT - ZOLINZA

N021991 001 7456219 Mar 11, 2027 DS

8093295 May 16, 2026 DP

8101663 Mar 04, 2023 U-892

RE38506 Nov 29, 2013 DS DP

ZIPRASIDONE HYDROCHLORIDE - ZIPRASIDONE HYDROCHLORIDE

A077560 001 PC Aug 29, 2012

ZIPRASIDONE HYDROCHLORIDE - ZIPRASIDONE HYDROCHLORIDE

A077560 002 PC Aug 29, 2012

ZIPRASIDONE HYDROCHLORIDE - ZIPRASIDONE HYDROCHLORIDE

A077560 003 PC Aug 29, 2012

ZIPRASIDONE HYDROCHLORIDE - ZIPRASIDONE HYDROCHLORIDE

A077560 004 PC Aug 29, 2012

ZOLPIDEM TARTRATE - INTERMEZZO

N022328 001 8242131 Aug 20, 2029 U-1266

8252809 Feb 16, 2025 DP

ZOLPIDEM TARTRATE - INTERMEZZO

N022328 002 8242131 Aug 20, 2029 U-1266

8252809 Feb 16, 2025 DP

Footnote: 1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR

314.53(d)(5). 2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor.

They may not be flagged with respect to other claims which may apply.

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )

Page 203: APPROVED DRUG PRODUCTS - WordPress.com · approved drug products to another applicant, or when an applicant changes ... levothyroxine sodium drug products. Levothyroxine Sodium (Mylan

B-1

PATENT AND EXCLUSIVITY TERMS

Due to space limitations in the patent and exclusivity columns,abbreviations and references have been developed. Refer to the APPROVED DRUG

PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 31st Edition for a full listing of patent and exclusivity terms (Abbreviations, Dosing Schedule, Indications,and Patent Use Codes).

The current complete list of patent terms is available athttp://www.accessdata.fda.gov/scripts/cder/ob/docs/pattermsall.cfm

The current complete list of patent terms is available athttp://www.accessdata.fda.gov/scripts/cder/ob/docs/excltermsall.cfm

DR.RUPN

ATHJI(

DR.R

UPAK

NATH )


Recommended