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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 | Seqens |
France |
POLYCARBON INDUSTRIES INC DBA PCI SYNTHESIS | 15244 | FLECAINIDE ACETATE USP | 2001-01-15 | Inactive | II | N/A | ||
28/06/2025 | Unimark Remedies |
India |
UNIMARK REMEDIES LTD | 19272 | FLECAINIDE ACETATE USP | 2006-03-23 | Active | II | N/A |