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List of Drug Master Files (DMF) of Choline Fenofibrate 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 Moehs Iberica
Spain
MOEHS IBERICA SL 24540 CHOLINE FENOFIBRATE 2011-01-07 Active II Complete 2015-03-30 2014-10-09
26/09/2024 CordenPharma
Germany
CORDEN PHARMA CHENOVE 20950 CHOLINE FENOFIBRATE DRUG SUBSTANCE 2007-10-15 Active II N/A