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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207026Orig1s000 CHEMISTRY REVIEW(S)

207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

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Page 1: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207026Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 3: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 4: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 5: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 6: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 7: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 8: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 9: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 10: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

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

VIBHAKAR J SHAH11/26/2014

MAHESH R RAMANADHAM11/26/2014

Reference ID: 3664816

Page 11: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

Reference ID: 3690411

Page 12: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

Reference ID: 3690411

Page 13: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

Reference ID: 3690411

Page 14: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 15: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 16: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

Reference ID: 3690411

Page 17: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 18: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 19: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 20: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 21: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 22: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 23: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 24: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 25: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 26: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 27: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 28: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 29: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 30: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 31: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 32: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 33: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 34: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 35: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 36: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 37: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant
Page 38: 207026Orig1s000 - Food and Drug Administration · Sub ect Reviewer CMC Memo to File NDA 18 Dec 2014 Phoxillium Re lacement Solution A roval recommendation Dr. Olen Ste hens Pursuant

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

KASTURI SRINIVASACHAR04/28/2014

OKPONANABOFA ERADIRI04/29/2014

ANGELICA DORANTES04/29/2014

OLEN M STEPHENS04/29/2014

Reference ID: 3497120