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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 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INDIA PVT LTD | 24531 | DOLASETRON MESYLATE MONOHYDRATE USP | 2011-01-06 | Inactive | II | N/A | ||
| 31/10/2025 | Emcure Pharmaceuticals |
India |
EMCURE PHARMACEUTICALS LTD | 24794 | DOLASETRON MESYLATE USP | 2011-03-28 | Active | II | N/A |

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