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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 | Apicore |
India |
APICORE US LLC | 20438 | FELBAMATE | 2007-04-12 | Inactive | II | N/A | ||
28/03/2025 | Emcure Pharmaceuticals |
India |
EMCURE PHARMACEUTICALS LTD | 29408 | FELBAMATE USP | 2015-06-26 | Active | II | Complete | 2015-10-02 | 2015-07-08 |