ANDA 79164, held by Chartwell. Flecainide Acetate.
As of Nov 14, 2026, ANDA 79164 (Flecainide Acetate), held by Chartwell, was first approved by FDA on Jul 9, 2009, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate is indicated for the prevention of — paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms — paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate is also indicated for the prevention of — documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life-threatening.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2009 | Original application | Approved | None posted |
| Flecainide Acetate50MG · tablet;oral | Flecainide Acetate | Discontinued |
| Flecainide Acetate100MG · tablet;oral | Flecainide Acetate | Discontinued |
| Flecainide Acetate150MG · tablet;oral | Flecainide Acetate | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
