Details for New Drug Application (NDA): 021938

NDA 021938 describes SUTENT, which is a drug marketed by Cppi Cv and is included in one NDA. It is available from two suppliers. Additional details are available on the SUTENT profile page.

The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.

Summary for 021938

Tradename:	SUTENT
Applicant:	Cppi Cv
Ingredient:	sunitinib malate
Patents:	0

Pharmacology for NDA: 021938

Mechanism of Action

Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 021938

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUTENT	sunitinib malate	CAPSULE;ORAL	021938	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0550	0069-0550-38	28 CAPSULE in 1 BOTTLE (0069-0550-38)
SUTENT	sunitinib malate	CAPSULE;ORAL	021938	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0770	0069-0770-38	28 CAPSULE in 1 BOTTLE (0069-0770-38)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 12.5MG BASE
Approval Date:	Jan 26, 2006	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jan 26, 2006	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jan 26, 2006	TE:	AB	RLD:	Yes

Complete Access Available with Subscription