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Last Updated: March 25, 2025

Details for New Drug Application (NDA): 218024

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NDA 218024 describes SUNITINIB MALATE, which is a drug marketed by Dr Reddys, Eugia Pharma, Fosun Wanbang, Mylan, Natco Pharma, Sun Pharm, and Teva Pharms Usa, 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 218024

Tradename:	SUNITINIB MALATE
Applicant:	Natco Pharma
Ingredient:	sunitinib malate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 12.5MG BASE
Approval Date:	Oct 24, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Oct 24, 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:	Oct 24, 2023	TE:	AB	RLD:	No

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