Treats mild to moderate heart failure. ANDA 214982, held by Aurobindo Pharma Ltd. Digoxin.
As of Nov 13, 2026, ANDA 214982 (Digoxin), held by Aurobindo Pharma Ltd, was first approved by FDA on Feb 8, 2022, with 1 approved supplement and 0 published complete response letters.
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 tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2022 | Original application | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 8, 2022 | Original application | Approved |
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
