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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 020838

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NDA 020838 describes ATACAND, which is a drug marketed by Ani Pharms and is included in two NDAs. It is available from five suppliers. Additional details are available on the ATACAND profile page.

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

Summary for 020838

Tradename:	ATACAND
Applicant:	Ani Pharms
Ingredient:	candesartan cilexetil
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020838

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Suppliers and Packaging for NDA: 020838

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATACAND	candesartan cilexetil	TABLET;ORAL	020838	NDA AUTHORIZED GENERIC	Par Pharmaceutical Inc.	49884-658	49884-658-09	90 TABLET in 1 BOTTLE (49884-658-09)
ATACAND	candesartan cilexetil	TABLET;ORAL	020838	NDA AUTHORIZED GENERIC	Par Pharmaceutical Inc.	49884-659	49884-659-09	90 TABLET in 1 BOTTLE (49884-659-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Jun 4, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Jun 4, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	16MG
Approval Date:	Jun 4, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020838

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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