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Download - 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8

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Page 1: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209381Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 3: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 4: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 5: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 6: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 7: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 8: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 9: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 10: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 11: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 12: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 13: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 14: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 15: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 16: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 17: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 18: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 19: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 20: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 21: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 22: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 23: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 24: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 25: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 26: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 27: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8

SarahIbrahim

Digitally signed by Sarah IbrahimDate: 10/20/2017 10:50:01AMGUID: 546b898a000820c3599fd87d16af9641

Moo JhongRhee

Digitally signed by Moo Jhong RheeDate: 10/20/2017 11:16:27AMGUID: 502d0913000029f9798ca689a802fa55

Page 28: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8
Page 29: 209381Orig1s000 · Hitesh Shroff Digitally signed by Hitesh Shroff Date: 1/15/2018 11:23:56AM GUID: 502d1ab500002afd219fd67e3b9c99c8

HiteshShroff

Digitally signed by Hitesh ShroffDate: 1/15/2018 11:23:56AMGUID: 502d1ab500002afd219fd67e3b9c99c8


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