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List of Drug Master Files (DMF) of Estriol 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 12141 ESTRIOL 1996-09-23 Active II N/A
26/09/2024 Bayer AG
Germany
PROQUINA SA 12476 ESTRIOL 1997-04-18 Inactive II N/A