Irbesartan

Treats hypertension. ANDA 202254, held by Macleods Pharms Ltd. Irbesartan.

As of Nov 15, 2026, ANDA 202254 (Irbesartan), held by Macleods Pharms Ltd, was first approved by FDA on Oct 3, 2012, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2012
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 3, 2012	Original application	Approved	None posted

Products

3 strengths and forms


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

All 9 submissions, including labeling and manufacturing supplements


Nov 25, 2025	Supplement 62Labeling · Standard review	Approved	None posted
Dec 8, 2021	Supplement 37Labeling · Standard review	Approved	None posted
Dec 8, 2021	Supplement 41Labeling · Standard review	Approved	None posted
May 6, 2021	Supplement 34Labeling · Standard review	Approved	None posted
Oct 24, 2018	Supplement 21Labeling · Standard review	Approved	None posted
Aug 9, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Mar 11, 2013	Supplement 2Manufacturing	Approved	None posted
Oct 3, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202254
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

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