APPLICATION
ANDA076278
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-14
LATEST ACTION
2015-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLECAINIDE ACETATEPrescription
FLECAINIDE ACETATE 50MG · TABLET · ORAL
FLECAINIDE ACETATEPrescription
FLECAINIDE ACETATE 100MG · TABLET · ORAL
FLECAINIDE ACETATEPrescription
FLECAINIDE ACETATE 150MG · TABLET · ORAL
Approval history
2015-02-17Manufacturing (CMC) · Supplement 5AP
2007-11-07Labeling · Supplement 3AP
2003-01-14OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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