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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 34452 | HYDRALAZINE HYDROCHLORIDE USP | 2019-12-24 | Active | II | Complete | 2020-07-02 | 2020-03-05 |
| 25/04/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 41646 | HYDRALAZINE HYDROCHLORIDE | 2025-03-27 | Active | II | N/A |
