Irbesartan

ANDA 200461, held by Pharmobedient. Irbesartan.

As of Nov 15, 2026, ANDA 200461 (Irbesartan), held by Pharmobedient, was first approved by FDA on Sep 27, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 27, 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
Sep 27, 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


Aug 4, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Sep 27, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200461
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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