ANDA 77492, held by Ohm Labs Inc. Valsartan.
As of Nov 14, 2026, ANDA 77492 (Valsartan), held by Ohm Labs Inc, was first approved by FDA on Jun 26, 2014, with 5 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 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 |
|---|---|---|---|
| Jun 26, 2014 | Original application | Approved |
| Aug 20, 2019 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 20, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 20, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 17, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 17, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 26, 2014 | Original application | Approved |
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
