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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 |