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List of Drug Master Files (DMF) of Betamethyl Epoxide 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 Aurisco Pharmaceutical
China
AURISCO PHARMACEUTICAL CO LTD 34027 16 BETA METHYL EPOXIDE 2019-12-27 Active II N/A
26/09/2024 Pfizer Inc
U.S.A
PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC 11848 BETAMETHYL EPOXIDE 1996-02-08 Active II N/A