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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 31858 | DOFETILIDE | 2017-07-24 | Active | II | Complete | 2018-04-06 | 2017-10-02 |
| 29/11/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 30718 | DOFETILIDE USP | 2017-08-10 | Active | II | Complete | 2017-09-14 | 2017-08-11 |
