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Generated: December 12, 2017

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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0143-9786-10 10 VIAL in 1 CARTON (0143-9786-10) > 2 mL in 1 VIAL (0143-9786-01)
ENALAPRILAT enalaprilat INJECTABLE;INJECTION 078687 ANDA West-ward Pharmaceutical Corp 0143-9787 0143-9787-10 10 VIAL in 1 CARTON (0143-9787-10) > 1 mL in 1 VIAL (0143-9787-01)

Summary for product number 001

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


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Novartis
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