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List of Drug Master Files (DMF) of Alprazolamum [INN-Latin] 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 Malladi Drugs & Pharmaceuticals Limited
India
MALLADI DRUGS AND PHARMACEUTICALS LTD 20448 ALPRAZOLAM 2007-04-10 Active II Complete 2023-07-17 2023-07-13
26/09/2024 Fermion Oy
Finland
FERMION OY 9043 ALPRAZOLAM 1991-04-04 Active II Complete 2020-12-30 2020-12-23