ANDA 215599, held by Yichang Humanwell. Flecainide Acetate.
As of Nov 14, 2026, ANDA 215599 (Flecainide Acetate), held by Yichang Humanwell, was first approved by FDA on Sep 8, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE In patients without structural heart disease, Flecainide Acetate Tablets, USP are 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 Tablets, USP are 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 |
|---|---|---|---|
| Sep 8, 2022 | Original application | Approved | None posted |
| Flecainide Acetate50MG · tablet;oral | Flecainide Acetate | Rx |
| Flecainide Acetate100MG · tablet;oral | Flecainide Acetate | Rx |
| Flecainide Acetate150MG · tablet;oral | Flecainide Acetate | Rx |
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
