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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215057

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NDA 215057 describes NELARABINE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Gland, Meitheal, MSN, Nexus, Shorla, Xgen Pharms, and Zydus Pharms, and is included in ten NDAs. It is available from twelve suppliers. Additional details are available on the NELARABINE profile page.

The generic ingredient in NELARABINE is nelarabine. There are two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

Summary for 215057

Tradename:	NELARABINE
Applicant:	Nexus
Ingredient:	nelarabine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Jun 2, 2023	TE:	AP	RLD:	No

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