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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 040615

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NDA 040615 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 040615

Tradename:	TESTOSTERONE CYPIONATE
Applicant:	Sandoz
Ingredient:	testosterone cypionate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Aug 10, 2006	TE:	AO	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Aug 10, 2006	TE:	AO	RLD:	No

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