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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
29/07/2025 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 35158 DEUTETRABENAZINE 2020-08-31 Active II Complete 2025-05-28 2025-05-20
29/07/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 33849 SD-809 DEUTETRABENAZINE 2019-12-26 Active II N/A