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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/06/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 38309 | ESLICARBAZEPINE ACETATE | 2023-04-25 | Active | II | N/A | ||
28/06/2025 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 31791 | ESLICARBAZEPINE ACETATE | 2017-06-05 | Active | II | Complete | 2018-07-27 | 2017-06-09 |