Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | USV Private Limited |
India |
USV PRIVATE LTD | 33211 | DOLASETRON MESYLATE USP | 2018-09-28 | Active | II | Complete | 2020-10-14 | 2018-09-26 |
| 28/10/2024 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INDIA PVT LTD | 24531 | DOLASETRON MESYLATE MONOHYDRATE USP | 2011-01-06 | Inactive | II | N/A |
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