Treats hypertension. ANDA 204011, held by Amneal Pharms. Valsartan.
As of Nov 14, 2026, ANDA 204011 (Valsartan), held by Amneal Pharms, was first approved by FDA on Jan 11, 2016, with 5 approved supplements and 0 published complete response letters.
Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Treatment of heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure. Post-myocardial infarction; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2016 | Original application | Approved | None posted |
| Oct 6, 2026 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jul 21, 2022 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jul 21, 2022 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 20, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 20, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 11, 2016 | 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
