BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
US Army
Merck
Mallinckrodt
Citi
Daiichi Sankyo
McKinsey
Fish and Richardson
Novartis

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086030

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NDA 086030 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Hikma Farmaceutica, Luitpold Pharms Inc, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, and West-ward Pharms Int, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the TESTOSTERONE CYPIONATE profile page.

The generic ingredient in TESTOSTERONE CYPIONATE is estradiol cypionate; testosterone cypionate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol cypionate; testosterone cypionate profile page.
Summary for 086030
Pharmacology for NDA: 086030
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 086030
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 086030 ANDA Dispensing Solutions, Inc. 55045-2092 55045-2092-2 1 VIAL, MULTI-DOSE in 1 CARTON (55045-2092-2) > 10 mL in 1 VIAL, MULTI-DOSE

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 leading biopharmaceutical companies globally:

Julphar
US Department of Justice
McKinsey
Farmers Insurance
Cantor Fitzgerald
Harvard Business School
Boehringer Ingelheim
UBS
Novartis

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