Dutoprol (metoprolol succinate and hydrochlorithiazide) tablets label
210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral...
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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210428Orig1s000 PRODUCT QUALITY REVIEW(S)
Transcript of 210428Orig1s000...This limit is as per the ICH M7 guidance option I (1.5 pg/day for a lifetime oral...
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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
210428Orig1s000
PRODUCT QUALITY REVIEW(S)
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WendyWilson- Lee
Digitally signed by Wendy Wilson- LeeDate: 11/30/2017 10:48:14AMGUID: 50816dbc000085595ca3284bbca465a8
Reference ID: 4213643
72 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
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MiltonSloan
Digitally signed by Milton SloanDate: 11/29/2017 09:49:38AMGUID: 508da72000029fa0e17abc24c6841f0a
WendyWilson- Lee
Digitally signed by Wendy Wilson- LeeDate: 11/29/2017 09:53:53AMGUID: 50816dbc000085595ca3284bbca465a8
Reference ID: 4213643
8 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page