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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Chinese Patent Office

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078687

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NDA 078687 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 078687
Applicant:Hikma Farmaceutica
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078687
Suppliers and Packaging for NDA: 078687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRILAT enalaprilat INJECTABLE;INJECTION 078687 ANDA West-ward Pharmaceutical Corp 0143-9786 N 0143-9786-10
ENALAPRILAT enalaprilat INJECTABLE;INJECTION 078687 ANDA West-ward Pharmaceutical Corp 0143-9787 N 0143-9787-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.25MG/ML
Approval Date:Dec 23, 2008TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Fish and Richardson

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