Candesartan Cilexetil

ANDA 202079, held by Apotex. Candesartan Cilexetil.

As of Nov 15, 2026, ANDA 202079 (Candesartan Cilexetil), held by Apotex, was first approved by FDA on Jan 10, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 10, 2014
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 10, 2014	Original application	Approved	None posted

Products

4 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Feb 12, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Jan 10, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202079
Drugs@FDA: Overview at FDA
Company: Apotex

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