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Details for New Drug Application (NDA): 086030

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NDA 086030 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Watson Labs, Sandoz, Sun Pharm Inds Ltd, Paddock Llc, Hikma Farmaceutica, Mylan Institutional, and Eurohlth Intl Sarl, and is included in ten NDAs. It is available from nine 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 NDA: 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 Actavis Pharma, Inc. 0591-3223 0591-3223-54 1 VIAL, SINGLE-DOSE in 1 CARTON (0591-3223-54) > 1 mL in 1 VIAL, SINGLE-DOSE
TESTOSTERONE CYPIONATE
testosterone cypionate
INJECTABLE;INJECTION 086030 ANDA Actavis Pharma, Inc. 0591-3223 0591-3223-79 1 VIAL, SINGLE-DOSE in 1 CARTON (0591-3223-79) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary 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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