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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 33845 | DANTROLENE SODIUM | 2019-06-17 | Active | II | N/A | ||
| 31/10/2025 | Veranova |
U.S.A |
VERANOVA LP | 20779 | DANTROLENE SODIUM (DTE) | 2007-08-16 | Active | II | N/A |

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