Details for New Drug Application (NDA): 211817

NDA 211817 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 211817

Tradename:	TESTOSTERONE CYPIONATE
Applicant:	Eugia Pharma
Ingredient:	testosterone cypionate
Patents:	0

Pharmacology for NDA: 211817

Mechanism of Action

Androgen Receptor Agonists

Suppliers and Packaging for NDA: 211817

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	211817	ANDA	Eugia US LLC	55150-276	55150-276-01	1 VIAL, MULTI-DOSE in 1 CARTON (55150-276-01) / 10 mL in 1 VIAL, MULTI-DOSE
TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	211817	ANDA	Eugia US LLC	55150-277	55150-277-01	1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Oct 20, 2023	TE:	AO	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Oct 20, 2023	TE:	AO	RLD:	No

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