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As of Nov 14, 2026, ANDA 203311 (Valsartan), held by Hetero Labs Ltd V, was first approved by FDA on Jan 5, 2015, with 5 approved supplements and 0 published complete response letters.
First approved: Jan 5, 2015
Supplements approved: 5
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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 to 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.
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
