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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 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 31858 | DOFETILIDE | 2017-07-24 | Active | II | Complete | 2018-04-06 | 2017-10-02 |
28/03/2025 | Veranova |
U.S.A |
VERANOVA LP | 27816 | 4245.C (MILLED) [DOFETILIDE] | 2014-02-25 | Active | II | Complete | 2014-07-18 | 2014-02-12 |