Olmesartan Medoxomil

ANDA 205192, held by Zydus Pharms. Olmesartan Medoxomil.

As of Nov 15, 2026, ANDA 205192 (Olmesartan Medoxomil), held by Zydus Pharms, was first approved by FDA on Apr 24, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 24, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 24, 2017	Original application	Approved	None posted

Products

3 strengths and forms


Olmesartan Medoxomil5MG · tablet;oral	Olmesartan Medoxomil	Rx
Olmesartan Medoxomil20MG · tablet;oral	Olmesartan Medoxomil	Rx
Olmesartan Medoxomil40MG · tablet;oral	Olmesartan Medoxomil	Rx

All 2 submissions, including labeling and manufacturing supplements


Jul 1, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Apr 24, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205192
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