Digoxin

Treats mild to moderate heart failure. ANDA 76363, held by Sun Pharm Inds Inc. Digoxin.

As of Nov 13, 2026, ANDA 76363 (Digoxin), held by Sun Pharm Inds Inc, was first approved by FDA on Jan 31, 2003, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2003
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Digoxin is a cardiac glycoside indicated for:

Treatment of mild to moderate heart failure in adults.
Increasing myocardial contractility in pediatric patients with heart failure.
Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. 1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 31, 2003	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Digoxin0.125MG · tablet;oral	Digoxin	Discontinued
Digoxin0.25MG · tablet;oral	Digoxin	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 7, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 32Labeling · Standard review	Approved	None posted
Jul 6, 2010	Supplement 12Labeling	Approved	None posted
Jun 14, 2007	Supplement 8Manufacturing	Approved	None posted
Jan 31, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76363
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters