Treats hypertension. ANDA 216460, held by Rubicon Research. Valsartan.
As of Nov 14, 2026, ANDA 216460 (Valsartan), held by Rubicon Research, was first approved by FDA on Jun 5, 2025, with 0 approved supplements and 0 published complete response letters.
Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension in adults and children six years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II-IV); Valsartan oral solution significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; Valsartan oral solution reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Valsartan4MG/ML · solution;oral | Valsartan | Rx |
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
