Details for New Drug Application (NDA): 021093

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NDA 021093 describes ATACAND HCT, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ATACAND HCT profile page.

The generic ingredient in ATACAND HCT 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 021093

Tradename:	ATACAND HCT
Applicant:	Ani Pharms
Ingredient:	candesartan cilexetil; hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 021093

Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 021093

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093	NDA	ANI Pharmaceuticals, Inc.	62559-650	62559-650-90	90 TABLET in 1 BOTTLE (62559-650-90)
ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093	NDA	ANI Pharmaceuticals, Inc.	62559-651	62559-651-90	90 TABLET in 1 BOTTLE (62559-651-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	16MG;12.5MG
Approval Date:	Sep 5, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	32MG;12.5MG
Approval Date:	Sep 5, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	32MG;25MG
Approval Date:	May 16, 2008	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021093

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	7,538,133*PED	⤷ Subscribe
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,721,263	⤷ Subscribe
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,534,534*PED	⤷ Subscribe
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