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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 218012

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NDA 218012 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 218012

Tradename:	SUNITINIB MALATE
Applicant:	Fosun Wanbang
Ingredient:	sunitinib malate
Patents:	0

Pharmacology for NDA: 218012

Mechanism of Action	Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 218012

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218012	ANDA	Novugen Pharma (USA) LLC.	82293-014	82293-014-10	28 CAPSULE in 1 BOTTLE (82293-014-10)
SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218012	ANDA	Novugen Pharma (USA) LLC.	82293-015	82293-015-10	28 CAPSULE in 1 BOTTLE (82293-015-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 12.5MG BASE
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	Aug 21, 2023	TE:	AB	RLD:	No

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