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List of Drug Master Files (DMF) of Ethyl Alcohol 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 ACS DOBFAR SPA
Italy
ANTIBIOTICOS SPA 3107 PREDNACINOLONE ALCOHOL, MICRONIZED & NON MICRONIZED 1977-12-27 Inactive II N/A
26/09/2024 CIE Alcohol
U.S.A
CENTRAL INDIANA ETHANOL LLC 38683 USP GRADE ETHYL ALCOHOL 2023-09-20 Active II N/A