Candesartan Cilexetil

Treats hypertension. ANDA 78702, held by Mylan. Candesartan Cilexetil.

As of Nov 15, 2026, ANDA 78702 (Candesartan Cilexetil), held by Mylan, was first approved by FDA on May 3, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: May 3, 2013
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Candesartan cilexetil tablets are 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 tablets reduce cardiovascular death and heart failure hospitalization. 1.1 Hypertension Candesartan cilexetil tablets are 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 4 submissions below

Date	Submission	Status	Documents
May 3, 2013	Original application	Approved	Letter

Products

4 strengths and forms


Candesartan Cilexetil4MG · tablet;oral	Candesartan Cilexetil	Rx
Candesartan Cilexetil8MG · tablet;oral	Candesartan Cilexetil	Rx
Candesartan Cilexetil16MG · tablet;oral	Candesartan Cilexetil	Rx
Candesartan Cilexetil32MG · tablet;oral	Candesartan Cilexetil	Rx

All 4 submissions, including labeling and manufacturing supplements


Apr 30, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Apr 30, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Apr 3, 2017	Supplement 3Manufacturing	Approved	None posted
May 3, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 78702
Drugs@FDA: Overview at FDA
Company: Mylan

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