Olmesartan Medoxomil

ANDA 202375, held by Torrent. Olmesartan Medoxomil.

As of Nov 15, 2026, ANDA 202375 (Olmesartan Medoxomil), held by Torrent, was first approved by FDA on Apr 24, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 24, 2017
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	Discontinued
Olmesartan Medoxomil20MG · tablet;oral	Olmesartan Medoxomil	Discontinued
Olmesartan Medoxomil40MG · tablet;oral	Olmesartan Medoxomil	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 29, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Apr 24, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 202375
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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