Flecainide Acetate

ANDA 75882, held by Ani Pharms. Flecainide Acetate.

As of Nov 14, 2026, ANDA 75882 (Flecainide Acetate), held by Ani Pharms, was first approved by FDA on Oct 28, 2002, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 28, 2002
Supplements approved: 1
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; all 2 submissions below

Date	Submission	Status	Documents
Oct 28, 2002	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

All 2 submissions, including labeling and manufacturing supplements


Nov 3, 2021	Supplement 13Manufacturing	Approved	None posted
Oct 28, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75882
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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