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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216510

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NDA 216510 describes NELARABINE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, 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. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

Summary for 216510

Tradename:	NELARABINE
Applicant:	Xgen Pharms
Ingredient:	nelarabine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Sep 5, 2024	TE:	AP	RLD:	No

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