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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 06/08/2025 | Maithri Drugs |
India |
MAITHRI LABORATORIES PRIVATE LTD | 33246 | IVABRADINE HYDROCHLORIDE | 2018-10-30 | Active | II | Complete | 2019-04-17 | 2019-03-19 |
| 29/07/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 32074 | IVABRADINE HYDROCHLORIDE | 2017-09-30 | Active | II | Complete | 2020-08-12 | 2020-07-22 |
