Treats mild to moderate heart failure. ANDA 213000, held by Vistapharm LLC. Digoxin.
As of Nov 13, 2026, ANDA 213000 (Digoxin), held by Vistapharm LLC, was first approved by FDA on Oct 4, 2019, with 0 approved supplements and 0 published complete response letters.
Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. ( 1.1, 1.3 ) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. 1.1 Heart Failure in Adults Digoxin Oral Solution is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Digoxin0.05MG/ML · elixir;oral | Digoxin | Rx |
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
