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List of Drug Master Files (DMF) of MolPort-002-051-370 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 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 18014 BACLOFEN 2005-01-20 Active II Complete 2013-01-08 2012-12-11
26/09/2024 Aspen API
Netherlands
FINE CHEMICALS CORP PTY LTD 6421 BACLOFEN 1986-06-18 Active II N/A