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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215843


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NDA 215843 describes SUNITINIB MALATE, which is a drug marketed by Dr Reddys, Eugia Pharma, Fosun Wanbang, MSN, Mylan, Natco Pharma, Sun Pharm, and Teva Pharms Usa, and is included in eight NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for 215843
Tradename:SUNITINIB MALATE
Applicant:Dr Reddys
Ingredient:sunitinib malate
Patents:0
Pharmacology for NDA: 215843
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 215843
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843 ANDA Dr.Reddys Laboratories Inc 43598-045 43598-045-28 4 BLISTER PACK in 1 CARTON (43598-045-28) / 7 CAPSULE in 1 BLISTER PACK (43598-045-70)
SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843 ANDA Dr.Reddys Laboratories Inc 43598-045 43598-045-63 28 CAPSULE in 1 BOTTLE (43598-045-63)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 12.5MG BASE
Approval Date:Apr 11, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Apr 11, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 37.5MG BASE
Approval Date:Apr 11, 2022TE:ABRLD:No

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Preferred Citation:

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