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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
04/06/2025 | Honour Lab |
India |
HONOUR LAB LTD | 28627 | NEBIVOLOL HYDROCHLORIDE | 2014-09-10 | Active | II | Complete | 2015-01-05 | 2014-10-07 |
04/06/2025 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 39313 | NEBIVOLOL HYDROCHLORIDE | 2024-03-15 | Active | II | Complete | 2024-04-25 | 2024-04-12 |