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List of Drug Master Files (DMF) of Dexfenfluramine 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 Immunophotonics
U.S.A
IMMUNOPHOTONICS INC 37937 IP-001 DRUG SUBSTANCE 2023-02-16 Active II N/A
26/09/2024 Servier
France
ORIL INDUSTRIE 10106 DEXFENFLURAMINE HYDROCHLORIDE 1993-02-26 Inactive II N/A