Details for New Drug Application (NDA): 021938
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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 |
Formulation / Manufacturing: | see details |
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 |
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