Details for New Drug Application (NDA): 085635

NDA 085635 describes DEPO-TESTOSTERONE, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the DEPO-TESTOSTERONE profile page.

The generic ingredient in DEPO-TESTOSTERONE is testosterone cypionate. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone cypionate profile page.

Summary for 085635

Tradename:	DEPO-TESTOSTERONE
Applicant:	Pfizer
Ingredient:	testosterone cypionate
Patents:	0

Pharmacology for NDA: 085635

Mechanism of Action

Androgen Receptor Agonists

Suppliers and Packaging for NDA: 085635

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEPO-TESTOSTERONE	testosterone cypionate	INJECTABLE;INJECTION	085635	ANDA	Pharmacia and Upjohn Company LLC	0009-0085	0009-0085-10	1 VIAL in 1 CARTON (0009-0085-10) / 10 mL in 1 VIAL
DEPO-TESTOSTERONE	testosterone cypionate	INJECTABLE;INJECTION	085635	ANDA	Pharmacia and Upjohn Company LLC	0009-0086	0009-0086-01	1 VIAL in 1 CARTON (0009-0086-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AO	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AO	RLD:	Yes

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