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208692Orig1s000 - Food and Drug Administration of Administration Oral Tablet Rx/OTC Dispensed...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208692Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208692Orig1s000 - Food and Drug Administration of Administration Oral Tablet Rx/OTC Dispensed Applicant Exelixis, Inc. US agent, if applicable SUBMISSION(S) REVIEWED DOCUMENT DATE

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208692Orig1s000

CHEMISTRY REVIEW(S)

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NDA 208692 Review 1

Drug Name/Dosage Form Cabozantinib (S)-maleate Strength 20mg, 40 mg, 60 mg Route of Administration Oral Tablet Rx/OTC Dispensed Applicant Exelixis, Inc. US agent, if applicable

SUBMISSION(S) REVIEWED DOCUMENT DATE DISCIPLINE(S) AFFECTED

Quality Review Team

DISCIPLINE REVIEWER BRANCH/DIVISION Drug Substance Xiang Wang Drug Product Xiang Wang

Process Ying Zhang Microbiology N/A

Facility Laura Fontan Biopharmaceutics Fang Wu

Regulatory Business Process Manager

Rabiya Laiq Kristine Leahy

Application Technical Lead Xiao Chen Laboratory (OTR) N/A

ORA Lead Paul Perdue Environmental Assessment (EA) Raanan Bloom

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---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

ROBYN S JORDON05/06/2016

Reference ID: 3927858

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