Details for New Drug Application (NDA): 019221

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NDA 019221 describes VASERETIC, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the VASERETIC profile page.

The generic ingredient in VASERETIC is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for 019221

Tradename:	VASERETIC
Applicant:	Bausch
Ingredient:	enalapril maleate; hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 019221

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

Suppliers and Packaging for NDA: 019221

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221	NDA	Bausch Health US, LLC	0187-0146	0187-0146-01	100 TABLET in 1 BOTTLE (0187-0146-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;25MG
Approval Date:	Oct 31, 1986	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG;12.5MG
Approval Date:	Jul 12, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019221

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	⤷ Sign Up	⤷ Sign Up
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986	⤷ Sign Up	⤷ Sign Up
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986	⤷ Sign Up	⤷ Sign Up
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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