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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209939Orig1s000 209940Orig1s000 PRODUCT QUALITY REVIEW(S)
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209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

Sep 15, 2020

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Page 1: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209939Orig1s000 209940Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 3: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 4: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 5: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 6: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 7: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

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Page 8: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 9: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

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Page 10: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 11: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 12: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 13: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 14: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 15: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

StephenMiller

Digitally signed by Stephen MillerDate: 11/06/2017 08:49:28PMGUID: 508da7210002a000609476bbecd040f0

Page 16: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 17: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

StephenMiller

Digitally signed by Stephen MillerDate: 11/06/2017 08:39:38PMGUID: 508da7210002a000609476bbecd040f0

Page 18: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 19: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 20: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 21: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 22: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 23: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

StephenMiller

Digitally signed by Stephen Miller

Date: 8/18/2017 11:56:29AM

GUID: 508da7210002a000609476bbecd040f0

Comments: ATL for NDA 209939

Page 24: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 25: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 26: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 27: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

JamesLaurenson

Digitally signed by James Laurenson

Date: 5/31/2017 03:26:07PM

GUID: 51dc6bdb0000c62de59b85452e59746f

MichaelFurness

Digitally signed by Michael Furness

Date: 6/01/2017 08:20:57AM

GUID: 502e8c7600003dd8331cf6eebf43697a

Page 28: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 29: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 30: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 31: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 32: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 33: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 34: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 35: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 36: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 37: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 38: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 39: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 40: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 41: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 42: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 43: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 44: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 45: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

QiZhang

Digitally signed by Qi Zhang

Date: 8/04/2017 11:52:42AM

GUID: 547e178000007695c91eb10380b07939

GerlieGieser

Digitally signed by Gerlie Gieser

Date: 8/04/2017 11:56:27AM

GUID: 507592ba00003d190b2ea34fe8fb8ccb

Page 46: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 47: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

StephenMiller

Digitally signed by Stephen Miller

Date: 8/18/2017 11:55:03AM

GUID: 508da7210002a000609476bbecd040f0

Comments: ATL for NDA 209939

Page 48: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 49: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 50: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 51: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 52: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 53: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

StephenMiller

Digitally signed by Stephen Miller

Date: 8/18/2017 01:40:07PM

GUID: 508da7210002a000609476bbecd040f0

Comments: ATL for NDA 209940

Page 54: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 55: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 56: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 57: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 58: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 59: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
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Page 61: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
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Page 63: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 64: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 65: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

JonathanBurgos

Digitally signed by Jonathan Burgos

Date: 8/04/2017 10:36:30AM

GUID: 5720cefa00de0a9047ad977609e16ac3

ErikaPfeiler

Digitally signed by Erika Pfeiler

Date: 8/04/2017 11:04:49AM

GUID: 502d1da500002b6a73a00c0e0dff6e1d

Page 66: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0
Page 67: 209939Orig1s000 209940Orig1s000 · 2017. 12. 4. · Stephen Miller Digitally signed by Stephen Miller Date: 11/06/2017 08:49:28PM GUID: 508da7210002a000609476bbecd040f0

StephenMiller

Digitally signed by Stephen Miller

Date: 8/18/2017 01:36:55PM

GUID: 508da7210002a000609476bbecd040f0

Comments: ATL for NDA 209940