Last Updated: September 25, 2026

Details for New Drug Application (NDA): 202079

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NDA 202079 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic, Apotex, Macleods Pharms, Mylan, Prinston Inc, Zydus Lifesciences, Apotex Inc, Pharmobedient, and Senores Pharms, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the CANDESARTAN CILEXETIL profile page.

The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

Summary for 202079

Tradename:	CANDESARTAN CILEXETIL
Applicant:	Apotex
Ingredient:	candesartan cilexetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Jan 10, 2014	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Jan 10, 2014	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	16MG
Approval Date:	Jan 10, 2014	TE:		RLD:	No

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