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Johnson and Johnson
Harvard Business School

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075578

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NDA 075578 describes ENALAPRILAT, which is a drug marketed by Athenex Inc, Hikma Farmaceutica, Hospira, and Teva Pharms Usa, and is included in six NDAs. It is available from three suppliers. Additional details are available on the ENALAPRILAT profile page.

The generic ingredient in ENALAPRILAT is enalaprilat. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalaprilat profile page.
Summary for 075578
Applicant:Teva Pharms Usa
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075578
Medical Subject Heading (MeSH) Categories for 075578
Suppliers and Packaging for NDA: 075578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRILAT enalaprilat INJECTABLE;INJECTION 075578 ANDA Teva Parenteral Medicines, Inc. 0703-8401 N 0703-8401-04
ENALAPRILAT enalaprilat INJECTABLE;INJECTION 075578 ANDA Teva Parenteral Medicines, Inc. 0703-8411 N 0703-8411-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.25MG/ML
Approval Date:Aug 22, 2000TE:APRLD:No

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