Irbesartan

Treats hypertension. ANDA 204774, held by Sciegen Pharms. Irbesartan.

As of Nov 15, 2026, ANDA 204774 (Irbesartan), held by Sciegen Pharms, was first approved by FDA on Dec 7, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 7, 2015
Supplements approved: 3
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 is 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 4 submissions below

Date	Submission	Status	Documents
Dec 7, 2015	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 4 submissions, including labeling and manufacturing supplements


May 6, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Aug 16, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Dec 6, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Dec 7, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204774
Drugs@FDA: Overview at FDA
Company: ScieGen 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