Valsartan tablets is 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 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 5, 2015 | Original application | Approved | None posted |
| Sep 13, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 13, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Dec 11, 2015 | Supplement 2Manufacturing | 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
