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Serving 500+ biopharmaceutical companies globally:

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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075458

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NDA 075458 describes ENALAPRILAT, which is a drug marketed by Athenex Inc, Hospira, Teva Pharms Usa, and Hikma Farmaceutica, and is included in six NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the enalaprilat profile page.

Summary for NDA: 075458

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075458

Suppliers and Packaging for NDA: 075458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 075458 ANDA Hospira, Inc. 0409-2122 0409-2122-01 1 VIAL in 1 CARTON (0409-2122-01) > 1 mL in 1 VIAL
INJECTABLE;INJECTION 075458 ANDA Hospira, Inc. 0409-2122 0409-2122-02 1 VIAL in 1 CARTON (0409-2122-02) > 2 mL in 1 VIAL

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
US Army
US Department of Justice
Harvard Business School
Chinese Patent Office

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