Treats hypertension. ANDA 77205, held by Chartwell Molecular. Irbesartan.
As of Nov 15, 2026, ANDA 77205 (Irbesartan), held by Chartwell Molecular, was first approved by FDA on Nov 14, 2012, with 2 approved supplements and 0 published complete response letters.
Irbesartan 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 diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. 1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2012 | Original application | Approved | None posted |
| Irbesartan75MG · tablet;oral | Irbesartan | Rx |
| Irbesartan150MG · tablet;oral | Irbesartan | Rx |
| Irbesartan300MG · tablet;oral | Irbesartan | Rx |
| Jul 13, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 18, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 14, 2012 | 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
