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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209241Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209241Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 3: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 4: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 5: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 6: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 7: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 8: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 9: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111

DavidClaffey

Digitally signed by David Claffey

Date: 2/13/2017 10:28:59AM

GUID: 508da71e00029e20b201195abff380c2

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

Page 10: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 11: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 12: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 13: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111

MichaelFurness

Digitally signed by Michael Furness

Date: 2/07/2017 12:59:52PM

GUID: 502e8c7600003dd8331cf6eebf43697a

JamesLaurenson

Digitally signed by James Laurenson

Date: 2/02/2017 09:09:39AM

GUID: 51dc6bdb0000c62de59b85452e59746f

Reference ID: 4083685

Page 14: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 15: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
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Page 18: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111

DavidClaffey

Digitally signed by David Claffey

Date: 2/13/2017 07:00:52PM

GUID: 508da71e00029e20b201195abff380c2

RaoKambhampati

Digitally signed by Rao Kambhampati

Date: 2/13/2017 04:49:09PM

GUID: 508da72000029fd06e8c9283b7414189

Reference ID: 4083685

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

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Page 20: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
Page 21: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111
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Page 23: 209241Orig1s000 - Food and Drug Administration › ... › 209241Orig1s000ChemR.pdf · 2017-05-18 · release and stability Impact of fonnulatlon change from clinical to Phase 111

StevenHertz

Digitally signed by Steven Hertz

Date: 2/06/2017 04:43:47PM

GUID: 508da717000297e0958d677af1408b44

RuthMoore

Digitally signed by Ruth Moore

Date: 2/06/2017 04:47:50PM

GUID: 530ccf7a000e6e04759cc41593877e4d

Reference ID: 4083685


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