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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215351


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NDA 215351 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, and Xiromed, and is included in fifteen NDAs. It is available from seventeen 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 215351
Tradename:TESTOSTERONE CYPIONATE
Applicant:Xiromed
Ingredient:testosterone cypionate
Patents:0
Pharmacology for NDA: 215351
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 215351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 215351 ANDA A-S Medication Solutions 50090-7584 50090-7584-0 1 VIAL, SINGLE-DOSE in 1 CARTON (50090-7584-0) / 1 mL in 1 VIAL, SINGLE-DOSE
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 215351 ANDA A-S Medication Solutions 50090-7585 50090-7585-0 1 VIAL, SINGLE-DOSE in 1 CARTON (50090-7585-0) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Apr 13, 2023TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Apr 13, 2023TE:AORLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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