Treats mild to moderate heart failure. ANDA 78556, held by Impax Labs. Digoxin.
As of Nov 14, 2026, ANDA 78556 (Digoxin), held by Impax Labs, was first approved by FDA on Jul 20, 2009, with 8 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2009 | Original application | Approved | None posted |
| Feb 9, 2026 | Supplement 26Labeling · Standard review | Approved | None posted |
| Nov 12, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Nov 12, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 12, 2020 | Supplement 21Labeling · Standard review | Approved | None posted |
| Nov 12, 2020 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 6, 2015 | Supplement 5Labeling | Approved | None posted |
| Apr 6, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 26, 2010 | Supplement 2Labeling | Approved | None posted |
| Jul 20, 2009 | Original application | Approved | None posted |
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
