Details for New Drug Application (NDA): 020033

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NDA 020033 describes LOTENSIN HCT, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from four suppliers. Additional details are available on the LOTENSIN HCT profile page.

The generic ingredient in LOTENSIN HCT is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.

Summary for 020033

Tradename:	LOTENSIN HCT
Applicant:	Validus Pharms
Ingredient:	benazepril hydrochloride; hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 020033

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure Increased Diuresis

Suppliers and Packaging for NDA: 020033

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0227	0574-0227-01	100 TABLET in 1 BOTTLE (0574-0227-01)
LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0228	0574-0228-01	100 TABLET in 1 BOTTLE (0574-0228-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 19, 1992	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;12.5MG
Approval Date:	May 19, 1992	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG;25MG
Approval Date:	May 19, 1992	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020033

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-001	May 19, 1992	4,410,520*PED	⤷ Subscribe
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-003	May 19, 1992	4,410,520*PED	⤷ Subscribe
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-004	May 19, 1992	4,410,520*PED	⤷ Subscribe
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-002	May 19, 1992	4,410,520*PED	⤷ Subscribe
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