Treats hypertension. ANDA 203534, held by Jubilant Generics. Irbesartan.
As of Nov 15, 2026, ANDA 203534 (Irbesartan), held by Jubilant Generics, was first approved by FDA on Feb 23, 2015, with 4 approved supplements and 0 published complete response letters.
Irbesartan tablets are 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 |
|---|---|---|---|
| Feb 23, 2015 | Original application | Approved | None posted |
| Irbesartan75MG · tablet;oral | Irbesartan | Rx |
| Irbesartan150MG · tablet;oral | Irbesartan | Rx |
| Irbesartan300MG · tablet;oral | Irbesartan | Rx |
| Oct 1, 2025 | Supplement 19Labeling · Standard review | Approved | None posted |
| Nov 1, 2022 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 30, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 2, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 23, 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
