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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 |