Treats hypertension. ANDA 204740, held by Amneal Pharms. Irbesartan.
As of Nov 15, 2026, ANDA 204740 (Irbesartan), held by Amneal Pharms, was first approved by FDA on Apr 17, 2018, with 4 approved supplements and 0 published complete response letters.
Irbesartan tablets are 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 |
|---|---|---|---|
| Apr 17, 2018 | Original application | Approved | None posted |
| Irbesartan75MG · tablet;oral | Irbesartan | Rx |
| Irbesartan150MG · tablet;oral | Irbesartan | Rx |
| Irbesartan300MG · tablet;oral | Irbesartan | Rx |
| Feb 23, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 23, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 23, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 23, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 17, 2018 | 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
