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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209570Orig1s000 PRODUCT QUALITY REVIEW(S)

209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental

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Page 1: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209570Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental
Page 3: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental
Page 4: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental
Page 5: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental
Page 6: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental
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GerlieGieser

Digitally signed by Gerlie Gieser

Date: 6/02/2017 11:55:27AM

GUID: 507592ba00003d190b2ea34fe8fb8ccb

ElsbethChikhale

Digitally signed by Elsbeth Chikhale

Date: 6/02/2017 12:13:34PM

GUID: 50743ccc000031928b54eba1769a5df9

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

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YongWang

Digitally signed by Yong Wang

Date: 6/05/2017 05:04:06PM

GUID: 508da7210002a01861739fd87b35adb9

BalajeeShanmugam

Digitally signed by Balajee Shanmugam

Date: 6/05/2017 08:36:37PM

GUID: 50758d5000003c1b1962e036ea11002c

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YongWang

Digitally signed by Yong Wang

Date: 8/11/2017 09:49:02AM

GUID: 508da7210002a01861739fd87b35adb9

BalajeeShanmugam

Digitally signed by Balajee Shanmugam

Date: 8/11/2017 11:03:09AM

GUID: 50758d5000003c1b1962e036ea11002c

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