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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 Granules India Limited
India
GRANULES INDIA LTD 37593 TRAZODONE HYDROCHLORIDE USP 2022-12-28 Active II Complete 2023-08-22 2023-07-17
28/03/2025 Fermion Oy
Finland
FERMION OY 4570 TRAZODONE HYDROCHLORIDE 1982-05-21 Active II N/A