Irbesartan

ANDA 79213, held by Zydus Pharms USA Inc. Irbesartan.

As of Nov 15, 2026, ANDA 79213 (Irbesartan), held by Zydus Pharms USA Inc, was first approved by FDA on Sep 27, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2012
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 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 4 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Nov 12, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Sep 27, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 79213
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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