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List of Drug Master Files (DMF) of Fluorometholone 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 Axplora
Germany
FARMABIOS SPA 35780 FLUOROMETHOLONE 2021-04-13 Active II Complete 2024-07-18 2024-06-12
26/09/2024 EUROAPI
France
EUROAPI FRANCE 4423 FLUOROMETHOLONE 1982-02-03 Active II Complete 2014-04-18 2014-04-11