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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209400Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 209400Orig1s000 - Food and Drug Administration...5. Process Selection (Unit Operations Summary The key manufacturing process steps are: The control strategy for each process step is

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209400Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209400Orig1s000 - Food and Drug Administration...5. Process Selection (Unit Operations Summary The key manufacturing process steps are: The control strategy for each process step is
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SwapanDe

Digitally signed by Swapan De

Date: 5/23/2017 08:26:54AM

GUID: 508da7220002a114329c9e07775b6e02

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HansongChen

Digitally signed by Hansong Chen

Date: 5/04/2017 11:41:19AM

GUID: 525d7d660003845a197a2e1682433d0d

Tien MienChen

Digitally signed by Tien Mien Chen

Date: 5/04/2017 01:29:12PM

GUID: 508da7240002a26723d38018ce005126

Page 32: 209400Orig1s000 - Food and Drug Administration...5. Process Selection (Unit Operations Summary The key manufacturing process steps are: The control strategy for each process step is

SwapanDe

Digitally signed by Swapan De

Date: 5/23/2017 08:42:00AM

GUID: 508da7220002a114329c9e07775b6e02

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