208751orig1s000...erin kim koushik paul juandria williams n/a anika lalmansingh muthukumar ramaswamy...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208751Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208751Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 3: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 4: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 5: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 6: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 7: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module

MuthukumarRamaswamy

Digitally signed by Muthukumar Ramaswamy

Date: 8/17/2017 10:36:46AM

GUID: 508da7210002a0c0870017f6c83398f4

Page 8: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 9: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 10: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 11: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 12: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 13: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 14: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module
Page 15: 208751Orig1s000...Erin Kim Koushik Paul Juandria Williams N/A Anika Lalmansingh Muthukumar Ramaswamy tal Lewis N/A Muthukumar Ramaswamy Page 1 of 7 DISCIPLINE(S) AFFECTED Quality (Module