Irbesartan

As of Nov 15, 2026, ANDA 77466 (Irbesartan), held by Sandoz, was first approved by FDA on Sep 27, 2012, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2012
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 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 6 submissions, including labeling and manufacturing supplements


Dec 21, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Aug 30, 2021	Supplement 10Labeling · Standard review	Approved	None posted
May 6, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Dec 10, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Sep 27, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 77466
Drugs@FDA: Overview at FDA
Company: Sandoz

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