Details for New Drug Application (NDA): 091244

NDA 091244 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 fifteen 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 091244

Tradename:	TESTOSTERONE CYPIONATE
Applicant:	Hikma Farmaceutica
Ingredient:	testosterone cypionate
Patents:	0

Pharmacology for NDA: 091244

Mechanism of Action

Androgen Receptor Agonists

Suppliers and Packaging for NDA: 091244

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	091244	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9005	0143-9005-01	1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL
TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	091244	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9659	0143-9659-01	1 mL in 1 VIAL (0143-9659-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	May 1, 2012	TE:	AO	RLD:	No

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