210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210428Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

210428Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 3: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 4: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 5: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 6: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 7: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 8: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 9: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 11/30/2017 10:48:14AMGUID: 50816dbc000085595ca3284bbca465a8

Reference ID: 4213643

72 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page

Page 10: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 11: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 12: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 13: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 14: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 15: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 16: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 17: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 18: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 19: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 20: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 21: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

Page 22: 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral exposure and the maximum daily dose for Metoprolol Succinate is 0.4 gm). No out

MiltonSloan

Digitally signed by Milton SloanDate: 11/29/2017 09:49:38AMGUID: 508da72000029fa0e17abc24c6841f0a

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 11/29/2017 09:53:53AMGUID: 50816dbc000085595ca3284bbca465a8

Reference ID: 4213643

8 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page

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