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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 37912 | DAROLUTAMIDE | 2023-03-30 | Active | II | Complete | 2023-04-20 | 2023-03-30 |
| 28/03/2025 | Hetero Drugs |
India |
HETERO LABS LTD | 38274 | DAROLUTAMIDE PREMIX | 2023-05-02 | Active | II | Complete | 2023-06-13 | 2023-04-25 |
