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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 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 29582 FLUVOXAMINE MALEATE USP 2015-07-22 Active II Complete 2018-01-04 2017-10-18
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 13913 FLUVOXAMINE MALEATE 1998-12-23 Active II N/A