Irbesartan

ANDA 90720, held by Watson Labs Inc. Irbesartan.

As of Nov 15, 2026, ANDA 90720 (Irbesartan), held by Watson Labs Inc, was first approved by FDA on Oct 12, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 12, 2012
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 12, 2012	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jan 26, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Oct 12, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90720
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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