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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
US Army
Mallinckrodt
Cipla
Cantor Fitzgerald
Harvard Business School
Deloitte
Colorcon
Citi

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085598

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NDA 085598 describes TESTOSTERONE ENANTHATE, which is a drug marketed by Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Watson Labs, and Watson Pharms Inc, and is included in eight NDAs. It is available from two suppliers. Additional details are available on the TESTOSTERONE ENANTHATE profile page.

The generic ingredient in TESTOSTERONE ENANTHATE is estradiol valerate; testosterone enanthate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol valerate; testosterone enanthate profile page.
Summary for 085598
Pharmacology for NDA: 085598
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 085598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 085598 ANDA Actavis Pharma, Inc. 0591-3221 N 0591-3221-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AORLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Department of Justice
AstraZeneca
Citi
Mallinckrodt
Accenture
Cerilliant
Dow
Moodys

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