Last Updated: November 8, 2026

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, Meitheal, MSN, Nexus, Pharmobedient, Shorla, 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 is one drug master file entry 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:	Pharmobedient
Ingredient:	nelarabine
Patents:	0

Pharmacology for NDA: 216510

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 216510

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216510	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0650	39822-0650-1	1 VIAL in 1 CARTON (39822-0650-1) / 50 mL in 1 VIAL
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216510	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0650	39822-0650-6	6 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL

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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