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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207742


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NDA 207742 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Am Regent, Cipla, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, Wilshire Pharms Inc, Xiromed, and Azurity, and is included in sixteen NDAs. It is available from seventeen suppliers. There are two patents protecting this drug. 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 207742
Tradename:TESTOSTERONE CYPIONATE
Applicant:Am Regent
Ingredient:testosterone cypionate
Patents:0
Pharmacology for NDA: 207742
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 207742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 207742 ANDA American Regent, Inc. 0517-1830 0517-1830-01 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 207742 ANDA Alvogen Inc. 47781-910 47781-910-91 10 VIAL, MULTI-DOSE in 1 CARTON (47781-910-91) / 10 mL in 1 VIAL, MULTI-DOSE (47781-910-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Jun 16, 2017TE:AORLD:No

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