ANDA 202223, held by Aurobindo Pharma Ltd. Valsartan.
As of Nov 14, 2026, ANDA 202223 (Valsartan), held by Aurobindo Pharma Ltd, was first approved by FDA on Jan 5, 2015, with 7 approved supplements and 0 published complete response letters.
Valsartan 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 5, 2015 | Original application | Approved | None posted |
| Dec 6, 2021 | Supplement 16Labeling · Standard review | Approved | None posted |
| Dec 6, 2021 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 6, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 16, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 16, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 16, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 9, 2015 | Supplement 2Labeling · 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
