Irbesartan

ANDA 90201, held by Hikma. Irbesartan.

As of Nov 15, 2026, ANDA 90201 (Irbesartan), held by Hikma, was first approved by FDA on Oct 15, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2012
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 15, 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 7 submissions, including labeling and manufacturing supplements


Dec 3, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Aug 3, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Feb 8, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jul 30, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Aug 9, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Nov 9, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Oct 15, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90201
Drugs@FDA: Overview at FDA
Company: Hikma

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