Flecainide Acetate

ANDA 210683, held by Regcon Holdings. Flecainide Acetate.

As of Nov 14, 2026, ANDA 210683 (Flecainide Acetate), held by Regcon Holdings, was first approved by FDA on Sep 16, 2020, with 0 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Sep 16, 2020	Original application	Approved	None posted

Products

3 strengths and forms


Flecainide Acetate50MG · tablet;oral	Flecainide Acetate	Rx
Flecainide Acetate100MG · tablet;oral	Flecainide Acetate	Rx
Flecainide Acetate150MG · tablet;oral	Flecainide Acetate	Rx

Identifiers

Application: ANDA 210683
Drugs@FDA: Overview at FDA
Company: Regcon Holdings

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