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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 216346

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NDA 216346 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 216346

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

Pharmacology for NDA: 216346

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 216346

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216346	ANDA	Amneal Pharmaceuticals LLC	70121-1743	70121-1743-4	6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Apr 4, 2023	TE:	AP	RLD:	No

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