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List of Drug Master Files (DMF) of Ethynodiol Diacetate 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 Aspen API
Netherlands
ASPEN OSS BV 7366 ETHYNODIOL DIACETATE 1988-03-04 Active II Complete 2016-09-14 2016-09-02
26/09/2024 Gedeon Richter
Hungary
GEDEON RICHTER LTD 1895 ETHYNODIOL DIACETATE 1986-07-11 Inactive II N/A