Benicar Hct

Treats hypertension. NDA 21532, held by Cosette. Hydrochlorothiazide; Olmesartan Medoxomil.

As of Nov 14, 2026, NDA 21532 (Benicar Hct), held by Cosette, was first approved by FDA on Jun 5, 2003, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 5, 2003
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Olmesartan medoxomil and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 olmesartan medoxomil and hydrochlorothiazide.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 5, 2003	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Benicar Hct12.5MG;20MG · tablet;oral	Hydrochlorothiazide; Olmesartan Medoxomil	RxReference drug
Benicar Hct12.5MG;40MG · tablet;oral	Hydrochlorothiazide; Olmesartan Medoxomil	RxReference drug
Benicar Hct25MG;40MG · tablet;oral	Hydrochlorothiazide; Olmesartan Medoxomil	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Apr 10, 2025	Supplement 38Labeling · Standard review	Approved	Label Letter
Aug 20, 2020	Supplement 37Labeling · Standard review	Approved	Label Letter
May 13, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 11, 2016	Supplement 15Labeling · Standard review	Approved	Label Letter
Sep 23, 2014	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 27, 2014	Supplement 25Labeling · Standard review	Approved	Letter Label
Jun 13, 2014	Supplement 24Labeling · Standard review	Approved	Label Letter
May 7, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 3, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 1, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 11, 2012	Supplement 21Labeling · Standard review	Approved	Label Letter
Sep 18, 2012	Supplement 20Labeling	Approved	Letter Label
Jan 18, 2012	Supplement 16Labeling	Approved	Label Letter
May 3, 2011	Supplement 14Labeling	Approved	Letter Label
May 3, 2011	Supplement 13Labeling	Approved	Letter Label
Nov 16, 2007	Supplement 8Labeling · Standard review	Approved	Letter
Jul 13, 2005	Supplement 4Labeling · Standard review	Approved	Letter Label
Nov 12, 2004	Supplement 1Labeling · Standard review	Approved	Letter
Jun 5, 2003	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21532
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