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Last Updated: December 28, 2024

Details for New Drug Application (NDA): 206233

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NDA 206233 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic, Apotex, Macleods Pharms Ltd, Mylan, Prinston Inc, Zydus Lifesciences, Apotex Inc, and Dr Reddys Labs Ltd, and is included in thirteen NDAs. It is available from six suppliers. Additional details are available on the CANDESARTAN CILEXETIL profile page.

The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are twenty-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 206233

Tradename:	CANDESARTAN CILEXETIL
Applicant:	Prinston Inc
Ingredient:	candesartan cilexetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	16MG
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	32MG
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

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