Azor

Treats hypertension, alone or with other antihypertensive agents. NDA 22100, held by Cosette. Amlodipine Besylate; Olmesartan Medoxomil.

As of Nov 14, 2026, NDA 22100 (Azor), held by Cosette, was first approved by FDA on Sep 26, 2007, with 22 approved supplements and 0 published complete response letters.

First approved: Sep 26, 2007
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amlodipine besylate and olmesartan medoxomil is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine besylate and olmesartan medoxomil.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


May 11, 2009	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Sep 26, 2007	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


AzorEQ 5MG BASE;20MG · tablet;oral	Amlodipine Besylate; Olmesartan Medoxomil	RxReference drug
AzorEQ 5MG BASE;40MG · tablet;oral	Amlodipine Besylate; Olmesartan Medoxomil	RxReference drug
AzorEQ 10MG BASE;20MG · tablet;oral	Amlodipine Besylate; Olmesartan Medoxomil	RxReference drug
AzorEQ 10MG BASE;40MG · tablet;oral	Amlodipine Besylate; Olmesartan Medoxomil	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Oct 2, 2020	Supplement 39Labeling · Standard review	Approved	Label Letter
Jan 5, 2017	Supplement 33Labeling · Standard review	Approved	Letter Label
Dec 9, 2016	Supplement 30Labeling · Standard review	Approved	Letter
Nov 1, 2016	Supplement 32Labeling · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 9, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 4, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 23, 2014	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 2, 2014	Supplement 25Labeling · Standard review	Approved	Letter Label
Jun 13, 2014	Supplement 24Labeling · Standard review	Approved	Letter Label
May 14, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 3, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 1, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 11, 2012	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 19Labeling	Approved	Letter Label
Jan 18, 2012	Supplement 16Labeling	Approved	Label Letter
Nov 14, 2011	Supplement 13Labeling	Approved	Letter Label
Nov 2, 2011	Supplement 14Labeling	Approved	Letter Label
May 19, 2011	Supplement 12Labeling	Approved	Letter Label
May 19, 2011	Supplement 10Labeling	Approved	Letter Label
May 11, 2009	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Aug 7, 2008	Supplement 3Labeling · Standard review	Approved	Letter
Sep 26, 2007	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 22100
Drugs@FDA: Overview at FDA
Company: Cosette

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