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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