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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201275


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NDA 201275 describes SUNITINIB MALATE, which is a drug marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Wanbang Biopharms, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the SUNITINIB MALATE profile page.

The generic ingredient in SUNITINIB MALATE 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 201275
Tradename:SUNITINIB MALATE
Applicant:Mylan
Ingredient:sunitinib malate
Patents:0
Pharmacology for NDA: 201275
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 201275
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 201275 ANDA Mylan Pharmaceuticals Inc. 0378-6678 0378-6678-28 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6678-28)
SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 201275 ANDA Mylan Pharmaceuticals Inc. 0378-6679 0378-6679-28 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6679-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 12.5MG BASE
Approval Date:Dec 6, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Dec 6, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 37.5MG BASE
Approval Date:Dec 6, 2021TE:ABRLD:No

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