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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 | Olon S.p.A |
Italy |
OLON SPA | 39659 | PRALSETINIB | 2024-05-24 | Active | II | Complete | 2024-06-14 | 2024-05-20 |
| 31/10/2025 | VALARY LAB PRIVATE LTD | 39814 | PRALSETINIB | 2024-04-15 | Active | II | Complete | 2024-06-26 | 2024-06-17 |
