Atacand

Treats hypertension. NDA 20838, held by Ani Pharms. Candesartan Cilexetil.

As of Nov 13, 2026, NDA 20838 (Atacand), held by Ani Pharms, was first approved by FDA on Jun 4, 1998, with 29 approved supplements and 0 published complete response letters.

First approved: Jun 4, 1998
Review: Standard
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization. 1.1 Hypertension Candesartan cilexetil is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Oct 22, 2009	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 5 Pediatric Amendment 4
May 18, 2005	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 22, 2005	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 13, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 4, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

4 strengths and forms


Atacand4MG · tablet;oral	Candesartan Cilexetil	RxReference drug
Atacand8MG · tablet;oral	Candesartan Cilexetil	RxReference drug
Atacand16MG · tablet;oral	Candesartan Cilexetil	RxReference drug
Atacand32MG · tablet;oral	Candesartan Cilexetil	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Jun 24, 2020	Supplement 41Labeling · Standard review	Approved	Label Letter
Feb 9, 2016	Supplement 39Labeling · Standard review	Approved	Letter Label
Feb 6, 2015	Supplement 36Labeling · Standard review	Approved	Letter Label
Apr 26, 2013	Supplement 38Labeling · Standard review	Approved	Letter Label
Feb 21, 2013	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 27, 2012	Supplement 35Labeling	Approved	Letter Label
Apr 13, 2012	Supplement 32Labeling	Approved	Label Letter
Jun 24, 2011	Supplement 33Labeling	Approved	Letter Label
Oct 22, 2009	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 5 Pediatric Amendment 4
Aug 17, 2006	Supplement 26Labeling · Standard review	Approved	Letter Label
May 18, 2005	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 22, 2005	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 16, 2004	Supplement 23Labeling · Standard review	Approved	Letter
Apr 23, 2003	Supplement 19Labeling · Standard review	Approved	Letter
Jan 22, 2003	Supplement 17Labeling · Standard review	Approved	Letter
Sep 13, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 28, 2001	Supplement 16Labeling · Standard review	Approved	None posted
Oct 4, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 7, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
May 24, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 2, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 29, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 27, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 14, 2000	Supplement 8Labeling · Standard review	Approved	Review
Dec 8, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 11, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 28, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 7, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 16, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 4, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 20838
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