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Treats mild to moderate heart failure. ANDA 83391, held by Hikma. Digoxin.
As of Nov 13, 2026, ANDA 83391 (Digoxin), held by Hikma, was first approved by FDA on Oct 24, 1975, with 13 approved supplements and 0 published complete response letters.
First approved: Oct 24, 1975
Supplements approved: 13
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. Control of resting ventricular rate in adults with chronic atrial fibrillation. 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. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.
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
