Irbesartan

Treats hypertension. ANDA 201531, held by Lupin Ltd. Irbesartan.

As of Nov 15, 2026, ANDA 201531 (Irbesartan), held by Lupin Ltd, was first approved by FDA on Oct 15, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2012
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Irbesartan tablet 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 15, 2012	Original application	Approved	None posted

Products

3 strengths and forms


Irbesartan75MG · tablet;oral	Irbesartan	Discontinued
Irbesartan150MG · tablet;oral	Irbesartan	Discontinued
Irbesartan300MG · tablet;oral	Irbesartan	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 16, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Dec 3, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Sep 14, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Sep 14, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Aug 22, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Oct 15, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Oct 15, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201531
Drugs@FDA: Overview at FDA
Company: Lupin

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