Irbesartan

Treats hypertension. ANDA 203071, held by Prinston Inc. Irbesartan.

As of Nov 15, 2026, ANDA 203071 (Irbesartan), held by Prinston Inc, was first approved by FDA on Sep 27, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2012
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

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
Sep 27, 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 8 submissions, including labeling and manufacturing supplements


Nov 4, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Mar 15, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Sep 15, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Sep 15, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Aug 22, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Sep 27, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 203071
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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