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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Fermion Oy |
Finland |
FERMION OY | 11315 | FLUOXETINE HYDROCHLORIDE USP | 1995-01-26 | Active | II | Complete | 2014-10-13 | 2014-10-02 |
24/02/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 12146 | FLUOXETINE HCI | 1996-10-02 | Active | II | Complete | 2017-02-22 | 2017-02-06 |