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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
209939Orig1s000 209940Orig1s000
PRODUCT QUALITY REVIEW(S)
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StephenMiller
Digitally signed by Stephen MillerDate: 11/06/2017 08:49:28PMGUID: 508da7210002a000609476bbecd040f0
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StephenMiller
Digitally signed by Stephen MillerDate: 11/06/2017 08:39:38PMGUID: 508da7210002a000609476bbecd040f0
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StephenMiller
Digitally signed by Stephen Miller
Date: 8/18/2017 11:56:29AM
GUID: 508da7210002a000609476bbecd040f0
Comments: ATL for NDA 209939
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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
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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
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StephenMiller
Digitally signed by Stephen Miller
Date: 8/18/2017 11:55:03AM
GUID: 508da7210002a000609476bbecd040f0
Comments: ATL for NDA 209939
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StephenMiller
Digitally signed by Stephen Miller
Date: 8/18/2017 01:40:07PM
GUID: 508da7210002a000609476bbecd040f0
Comments: ATL for NDA 209940
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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
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StephenMiller
Digitally signed by Stephen Miller
Date: 8/18/2017 01:36:55PM
GUID: 508da7210002a000609476bbecd040f0
Comments: ATL for NDA 209940