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Last Updated: April 23, 2024

Details for New Drug Application (NDA): 018998

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NDA 018998 describes VASOTEC, which is a drug marketed by Biovail Labs Intl and Bausch and is included in two NDAs. It is available from six suppliers. Additional details are available on the VASOTEC profile page.

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

Summary for 018998

Tradename:	VASOTEC
Applicant:	Bausch
Ingredient:	enalapril maleate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018998

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

Medical Subject Heading (MeSH) Categories for 018998

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Suppliers and Packaging for NDA: 018998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VASOTEC	enalapril maleate	TABLET;ORAL	018998	NDA	Bausch Health US LLC	0187-0140	0187-0140-30	30 TABLET in 1 BOTTLE (0187-0140-30)
VASOTEC	enalapril maleate	TABLET;ORAL	018998	NDA	Bausch Health US LLC	0187-0140	0187-0140-90	90 TABLET in 1 BOTTLE (0187-0140-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 24, 1985	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 24, 1985	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Dec 24, 1985	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018998

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	⤷ Try a Trial	⤷ Try a Trial
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985	⤷ Try a Trial	⤷ Try a Trial
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988	⤷ Try a Trial	⤷ Try a Trial
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-001	Dec 24, 1985	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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