ANDA 205536, held by Alkem Labs Ltd. Valsartan.
As of Nov 14, 2026, ANDA 205536 (Valsartan), held by Alkem Labs Ltd, was first approved by FDA on Mar 12, 2019, with 1 approved supplement and 0 published complete response letters.
Valsartan tablet is 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 |
|---|---|---|---|
| Mar 12, 2019 | Original application | Approved | None posted |
| Nov 6, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 12, 2019 | 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
