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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 | 12444 | ENTACAPONE | 1997-03-26 | Active | II | N/A | ||
24/02/2025 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 23937 | ENTACAPONE USP | 2010-06-30 | Active | II | Complete | 2016-05-24 | 2015-09-29 |