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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 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 39313 | NEBIVOLOL HYDROCHLORIDE | 2024-03-15 | Active | II | Complete | 2024-04-25 | 2024-04-12 |
28/03/2025 | Cadila Pharmaceuticals |
India |
CADILA PHARMACEUTICALS LTD | 21152 | NEBIVOLOL HYDROCHLORIDE | 2007-12-08 | Active | II | Complete | 2014-03-25 | 2013-09-11 |