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List of Drug Master Files (DMF) of Bexarotene 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 Apicore LLC
India
APICORE US LLC 23631 BEXAROTENE 2010-04-26 Active II Complete 2015-08-07 2015-07-29
26/09/2024 Catalent Pharma Solutions
U.S.A
CATALENT PHARMA SOLUTIONS LLC 14086 TARGRETIN 75 MG SOFT-GELATIN CAPSULE 1999-04-19 Inactive II N/A