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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 206368


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NDA 206368 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Am Regent, Caplin One Labs, Cipla, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, Wilshire Pharms Inc, and Xiromed, and is included in fifteen NDAs. It is available from eighteen 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 206368
Tradename:TESTOSTERONE CYPIONATE
Applicant:Wilshire Pharms Inc
Ingredient:testosterone cypionate
Patents:0
Pharmacology for NDA: 206368
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 206368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 206368 ANDA A-S Medication Solutions 50090-7435 50090-7435-0 1 VIAL, MULTI-DOSE in 1 CARTON (50090-7435-0) / 10 mL in 1 VIAL, MULTI-DOSE
TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 206368 ANDA Wilshire Pharmaceuticals 52536-625 52536-625-01 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Apr 24, 2019TE:AORLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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