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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 one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SUTENT profile page.

The generic ingredient in SUTENT is sunitinib malate. There are five drug master file entries for this compound. One supplier is listed for this compound. There are four tentative approvals for this compound. Additional details are available on the sunitinib malate profile page.

Summary for NDA: 021938

Tradename:
SUTENT
Applicant:
Cppi Cv
Ingredient:
sunitinib malate
Patents:3
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 12.5MG BASE
Approval Date:Jan 26, 2006TE:ABRLD:No
Patent:7,125,905Patent Expiration:Feb 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,211,600Patent Expiration:Dec 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB
Patent:6,573,293Patent Expiration:Feb 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB


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