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List of Drug Master Files (DMF) of Prestwick2_001041 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 ChemWerth Inc
U.S.A
CHEMWERTH INC 20500 ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE 2007-04-30 Active II Complete 2013-06-24 2013-06-13
26/09/2024 Bachem AG
Switzerland
BACHEM SA 20234 ETOMIDATE 2007-01-29 Active II Complete 2014-10-16 2014-10-14