Olmesartan Medoxomil

ANDA 206372, held by Micro Labs. Olmesartan Medoxomil.

As of Nov 15, 2026, ANDA 206372 (Olmesartan Medoxomil), held by Micro Labs, was first approved by FDA on Sep 17, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 17, 2019
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
Sep 17, 2019	Original application	Approved	None posted

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jul 1, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Sep 17, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 206372
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

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