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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 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 34452 | HYDRALAZINE HYDROCHLORIDE USP | 2019-12-24 | Active | II | Complete | 2020-07-02 | 2020-03-05 |
28/03/2025 | Alivus Life Sciences |
India |
GLENMARK LIFE SCIENCES LTD | 35807 | HYDRALAZINE HYDROCHLORIDE USP | 2021-03-30 | Active | II | Complete | 2021-06-16 | 2021-06-02 |