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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Synthon Pharmaceuticals |
Netherlands |
SYNTHON BV | 40289 | TIVOZANIB HYDROCHLORIDE MONOHYDRATE | 2024-09-10 | Active | II | Complete | 2024-10-09 | 2024-09-09 |
28/03/2025 | VALARY LAB PRIVATE LTD | 40806 | TIVOZANIB HYDROCHLORIDE MONOHYDRATE | 2024-12-12 | Active | II | Complete | 2025-01-28 | 2024-12-26 |