Atacand Hct

Treats hypertension. NDA 21093, held by Ani Pharms. Candesartan Cilexetil; Hydrochlorothiazide.

As of Nov 14, 2026, NDA 21093 (Atacand Hct), held by Ani Pharms, was first approved by FDA on Sep 5, 2000, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2000
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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 candesartan cilexetil and hydrochlorothiazide tablets.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Sep 5, 2000	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Atacand Hct16MG;12.5MG · tablet;oral	Candesartan Cilexetil; Hydrochlorothiazide	RxReference drug
Atacand Hct32MG;12.5MG · tablet;oral	Candesartan Cilexetil; Hydrochlorothiazide	RxReference drug
Atacand Hct32MG;25MG · tablet;oral	Candesartan Cilexetil; Hydrochlorothiazide	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 21Labeling · Standard review	Approved	Label Letter
Feb 9, 2016	Supplement 19Labeling · Standard review	Approved	Label Letter
Feb 9, 2015	Supplement 16Labeling	Approved	Letter Label
Apr 26, 2013	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 29, 2012	Supplement 15Labeling	Approved	Letter Label
Jun 14, 2011	Supplement 13Labeling	Approved	Letter Label
Mar 11, 2011	Supplement 12Labeling	Approved	Letter Label
May 16, 2008	Supplement 8Manufacturing	Approved	Letter
Aug 17, 2006	Supplement 6Labeling · Standard review	Approved	Label Letter
Dec 16, 2004	Supplement 4Labeling · Standard review	Approved	Letter
Jul 3, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 28, 2001	Supplement 1Labeling · Standard review	Approved	None posted
Sep 5, 2000	Original applicationNew combination · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21093
Drugs@FDA: Overview at FDA
Company: ANI 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