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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