Details for New Drug Application (NDA): 019851

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NDA 019851 describes LOTENSIN, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the LOTENSIN profile page.

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

Summary for 019851

Tradename:	LOTENSIN
Applicant:	Validus Pharms
Ingredient:	benazepril hydrochloride
Patents:	0

Pharmacology for NDA: 019851

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

Suppliers and Packaging for NDA: 019851

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851	NDA	Validus Pharmaceuticals LLC	30698-448	30698-448-01	100 TABLET in 1 BOTTLE (30698-448-01)
LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851	NDA	Validus Pharmaceuticals LLC	30698-449	30698-449-01	100 TABLET in 1 BOTTLE (30698-449-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 25, 1991	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 25, 1991	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 25, 1991	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019851

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-001	Jun 25, 1991	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-004	Jun 25, 1991	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-003	Jun 25, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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