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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 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 31791 | ESLICARBAZEPINE ACETATE | 2017-06-05 | Active | II | Complete | 2018-07-27 | 2017-06-09 |
28/03/2025 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 33028 | ESLICARBAZEPINE ACETATE | 2018-08-09 | Active | II | N/A |