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List of Drug Master Files (DMF) of Clofibrate 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 ACIC Europe API & Pharmaceuticals
Cyprus
ACIC LTD 2976 CLOFIBRATE B/P/USP/NF 1977-06-23 Inactive II N/A
26/09/2024 Industriale Chimica
Italy
INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA 5407 CLOFIBRATE USP 1984-04-20 Inactive II N/A