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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208587Orig1s000 PRODUCT QUALITY REVIEW(S)

208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

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Page 1: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208587Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 3: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 4: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 5: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 6: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 7: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 8: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

RajanPragani

Digitally signed by Rajan Pragani

Date: 6/15/2017 09:08:29AM

GUID: 578e502f005503985deca4ae5b7e95fa

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

Page 9: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 10: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 11: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 12: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 13: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

RajanPragani

Digitally signed by Rajan Pragani

Date: 6/16/2017 10:29:25AM

GUID: 578e502f005503985deca4ae5b7e95fa

BenStevens

Digitally signed by Ben Stevens

Date: 6/16/2017 10:38:49AM

GUID: 5432b4d800086115752a874a47534532

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

Page 14: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 15: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 16: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 17: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

RajanPragani

Digitally signed by Rajan Pragani

Date: 6/16/2017 01:23:15PM

GUID: 578e502f005503985deca4ae5b7e95fa

Page 18: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 19: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master
Page 20: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

RajanPragani

Digitally signed by Rajan Pragani

Date: 6/15/2017 09:08:11AM

GUID: 578e502f005503985deca4ae5b7e95fa

Page 21: 208587Orig1s000 - Food and Drug Administration · Rajan Pragani Ra.anPra ani Zhao an Men Ra.anPra ani E hrem Hunde n/a Rabiya Laiq Ra.anPra ani n/a Katherine Jacobitz Drug Master

RajanPragani

Digitally signed by Rajan Pragani

Date: 6/19/2017 04:47:45PM

GUID: 578e502f005503985deca4ae5b7e95fa