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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208026Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208026Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 3: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 4: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 5: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 6: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 7: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 8: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 9: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 10: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 11: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 12: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 13: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 14: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 15: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 16: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 17: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 18: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 19: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 20: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 21: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 22: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 23: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 24: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 25: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 26: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 27: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 28: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 29: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 30: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 31: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 32: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 33: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 34: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 35: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 36: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 37: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 38: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 39: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 40: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 41: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical
Page 42: 208026Orig1s000 - Food and Drug Administration · QUALITY REVIEW Recommendation ... and commercial product. 1. 2. BCS Classification: ... definition pvovided under USP I Pharmaceutical

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

JONATHAN T DOW06/06/2016

Reference ID: 3942163


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