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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
27/09/2025 PCAS
France
PCAS 34214 Estetrol Monohydrate 2019-11-27 Active II N/A
27/09/2025 Gedeon Richter
Hungary
GEDEON RICHTER PLC 37136 ESTETROL MONOHYDRATE 2022-06-10 Active II N/A