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Generated: December 15, 2018

DrugPatentWatch Database Preview

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 Valeant Pharms North 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. Forty suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
Summary for 018998
Tradename:VASOTEC
Applicant:Valeant Pharms North
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 Valeant Pharmaceuticals North America LLC 0187-0140 0187-0140-30 30 TABLET in 1 BOTTLE (0187-0140-30)
VASOTEC enalapril maleate TABLET;ORAL 018998 NDA Valeant Pharmaceuticals North America LLC 0187-0140 0187-0140-90 90 TABLET in 1 BOTTLE (0187-0140-90)

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
Valeant Pharms North VASOTEC enalapril maleate TABLET;ORAL 018998-005 Jul 26, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Teva
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Federal Trade Commission
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