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McKinsey
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040530

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NDA 040530 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 040530
Pharmacology for NDA: 040530
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 040530
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 040530 ANDA Paddock Laboratories, LLC 0574-0820 N 0574-0820-10
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 040530 ANDA Paddock Laboratories, LLC 0574-0820 N 0574-0820-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Jan 31, 2005TE:AORLD:No

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