Flecainide Acetate

ANDA 76278, held by Hikma. Flecainide Acetate.

As of Nov 14, 2026, ANDA 76278 (Flecainide Acetate), held by Hikma, was first approved by FDA on Jan 14, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2003
Supplements approved: 2
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 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 14, 2003	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 3 submissions, including labeling and manufacturing supplements


Feb 17, 2015	Supplement 5Manufacturing	Approved	None posted
Nov 7, 2007	Supplement 3Labeling	Approved	None posted
Jan 14, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76278
Drugs@FDA: Overview at FDA
Company: Hikma

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