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Generated: December 13, 2017

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 four 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:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
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 0187-0140-90 90 TABLET in 1 BOTTLE (0187-0140-90)
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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 018998

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-001Dec 24, 1985► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-005Jul 26, 1988► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-003Dec 24, 1985► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-002Dec 24, 1985► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Medtronic
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