ANDA 218991, held by Zydus Lifesciences. Valsartan.
As of Nov 14, 2026, ANDA 218991 (Valsartan), held by Zydus Lifesciences, was first approved by FDA on Jul 22, 2024, with 0 approved supplements and 0 published complete response letters.
Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2024 | 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
