Digoxin

Treats mild to moderate heart failure. ANDA 77002, held by Hikma. Digoxin.

As of Nov 13, 2026, ANDA 77002 (Digoxin), held by Hikma, was first approved by FDA on Oct 30, 2007, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 30, 2007
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Digoxin Tablets are 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 Tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets increase left ventricular ejection fraction and improve 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
Oct 30, 2007	Original application	Approved	None posted

Products

2 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 7, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Oct 7, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Nov 12, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Nov 12, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Nov 12, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Feb 23, 2015	Supplement 4Manufacturing	Approved	None posted
Dec 30, 2011	Supplement 6Labeling	Approved	None posted
Oct 30, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77002
Drugs@FDA: Overview at FDA
Company: Hikma

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