Irbesartan

ANDA 77159, held by Teva Pharms. Irbesartan.

As of Nov 15, 2026, ANDA 77159 (Irbesartan), held by Teva Pharms, was first approved by FDA on Mar 30, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 30, 2012	Original application	Approved	Letter

Products

3 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Jan 31, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 9Labeling · Standard review	Approved	None posted
Nov 12, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Dec 10, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Mar 30, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 77159
Drugs@FDA: Overview at FDA
Company: Teva 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