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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 218554

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NDA 218554 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 218554

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

Pharmacology for NDA: 218554

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 218554

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	218554	ANDA	Alembic Pharmaceuticals Limited	46708-813	46708-813-50	1 VIAL in 1 CARTON (46708-813-50) / 50 mL in 1 VIAL
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	218554	ANDA	Alembic Pharmaceuticals Limited	46708-813	46708-813-63	6 VIAL in 1 CARTON (46708-813-63) / 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:	Aug 1, 2024	TE:	AP	RLD:	No

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