210496orig1s000 - food and drug administration · rohit tiwari digitally signed by rohit tiwari...
TRANSCRIPT
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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
210496Orig1s000
PRODUCT QUALITY REVIEW(S)
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RohitTiwari
Digitally signed by Rohit TiwariDate: 5/29/2018 10:59:35AMGUID: 577417d000782195748a7e1e7b7209f5
AnamitroBanerjee
Digitally signed by Anamitro BanerjeeDate: 5/29/2018 11:05:57AMGUID: 5075764700003844b7bc89632228509f
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Table of Contents 1. Table of Contents ................................................................................ 1 2. Quality Review Data Sheet ................................................................ 3 3. Executive Summary ............................................................................ 5 4. ASSESSMENT OF THE DRUG SUBSTANCE ............................ 11 5. ASSESSMENT OF THE DRUG PRODUCT ................................ 90
a. ENVIRONMENTAL ANALYSIS ...................................... 124 6. ASSESSMENT OF THE LABELING.......................................... 127 7. ASSESSMENT OF THE PROCESS ............................................ 135 8. ASSESSMENT OF THE FACILITIES........................................ 165 9. ASSESSMENT OF THE BIOPHARMACEUTICS ................... 180
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RohitTiwari
Digitally signed by Rohit TiwariDate: 2/26/2018 09:58:24AMGUID: 577417d000782195748a7e1e7b7209f5
113 Page(s) have been Withheld in Full as b4 (CCI/TS) immediately following this page
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RohitTiwari
Digitally signed by Rohit TiwariDate: 2/12/2018 01:52:06PMGUID: 577417d000782195748a7e1e7b7209f5
AnamitroBanerjee
Digitally signed by Anamitro BanerjeeDate: 2/12/2018 01:54:49PMGUID: 5075764700003844b7bc89632228509f
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RohitTiwari
Digitally signed by Rohit TiwariDate: 2/14/2018 05:21:22PMGUID: 577417d000782195748a7e1e7b7209f5
AnamitroBanerjee
Digitally signed by Anamitro BanerjeeDate: 2/15/2018 04:03:02PMGUID: 5075764700003844b7bc89632228509f
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ZhuojunZhao
Digitally signed by Zhuojun ZhaoDate: 2/13/2018 12:57:33PMGUID: 508da6fd000284770cf4eecbae074722
OkponanabofaEradiri
Digitally signed by Okponanabofa EradiriDate: 2/13/2018 01:04:36PMGUID: 50bdfe8d00003559ede66be3fd299f65
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RohitTiwari
Digitally signed by Rohit TiwariDate: 2/27/2018 10:00:53AMGUID: 577417d000782195748a7e1e7b7209f5