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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
28/03/2025 Bachem AG
Switzerland
BACHEM AG 13822 LEUPROLIDE ACETATE 1998-11-06 Active II Complete 2016-09-02 2016-04-29
28/03/2025 Sanofi
France
GENZYME CORP 14440 LEUPROLIDE ACETATE 1999-10-08 Inactive II N/A