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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 34452 | HYDRALAZINE HYDROCHLORIDE USP | 2019-12-24 | Active | II | Complete | 2020-07-02 | 2020-03-05 |
28/10/2024 | Apothecon Pharmaceuticals |
India |
NAVINTA LLC | 19904 | HYDRALAZINE HYDROCHLORIDE USP | 2006-10-26 | Active | II | N/A |
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