Last Updated: November 13, 2026

Details for New Drug Application (NDA): 216038

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NDA 216038 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 216038

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

Pharmacology for NDA: 216038

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 216038

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216038	ANDA	Meitheal Pharmaceuticals Inc	71288-165	71288-165-54	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Jan 10, 2023	TE:	AP	RLD:	No

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