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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
26/04/2025 | Alivus Life Sciences |
India |
ALIVUS LIFE SCIENCES LTD | 40992 | TIVOZANIB HYDROCHLORIDE | 2024-12-18 | Active | II | Complete | 2025-01-06 | 2024-12-23 |
25/04/2025 | Synthon Pharmaceuticals |
Netherlands |
SYNTHON BV | 40289 | TIVOZANIB HYDROCHLORIDE MONOHYDRATE | 2024-09-10 | Active | II | Complete | 2024-10-09 | 2024-09-09 |