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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 | Fermion Oy |
Finland |
FERMION OY | 33361 | NINTEDANIB ESYLATE | 2019-01-02 | Active | II | Complete | 2019-03-26 | 2018-12-20 |
28/03/2025 | Veranova |
U.S.A |
VERANOVA LP | 32511 | NINTEDANIB ESYLATE | 2018-03-29 | Active | II | Complete | 2018-04-27 | 2018-03-30 |