ANDA 203536, held by Jubilant Generics. Valsartan.
As of Nov 14, 2026, ANDA 203536 (Valsartan), held by Jubilant Generics, was first approved by FDA on Jan 5, 2015, with 4 approved supplements and 0 published complete response letters.
1INDICATIONS AND USAGE Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years 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 |
|---|---|---|---|
| Jan 5, 2015 | Original application | Approved | None posted |
| Aug 17, 2022 | Supplement 16Manufacturing | Approved | None posted |
| May 5, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 5, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 5, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 5, 2015 | 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
