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List of Drug Master Files (DMF) of Prestwick3_000218 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 DINAMITE DIPHARMA SPA 8034 FENBUFEN 1989-04-25 Inactive II N/A
26/09/2024 LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO 4892 FENBUFEN MNFG BY CYANAMID OF GREAT BRITAIN, LIMITED 1982-12-27 Inactive II N/A