BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Citi
Moodys
Baxter
Julphar
Dow
Teva
Cerilliant
Deloitte
McKinsey
AstraZeneca

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091120

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NDA 091120 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 091120
Pharmacology for NDA: 091120
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 091120
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 091120 ANDA West-Ward Pharmaceuticals Corp 0143-9750 0143-9750-01 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Sep 18, 2012TE:AORLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
US Department of Justice
Daiichi Sankyo
Cerilliant
Dow
Citi
Deloitte
QuintilesIMS

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