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Last Updated: June 22, 2021

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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 eight 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-two 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
Medical Subject Heading (MeSH) Categories for 018998
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)
Paragraph IV (Patent) Challenges for 018998
Tradename Dosage Ingredient NDA Submissiondate
VASOTEC TABLET;ORAL enalapril maleate 018998

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 24, 1985TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 24, 1985TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 24, 1985TE:ABRLD:Yes

Expired US Patents for NDA 018998

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

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