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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021938


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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. Eleven 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 ActionProtein 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:RXDosage:CAPSULE;ORALStrengthEQ 12.5MG BASE
Approval Date:Jan 26, 2006TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Jan 26, 2006TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Jan 26, 2006TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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