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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 214809

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NDA 214809 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 214809

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

Pharmacology for NDA: 214809

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 214809

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	214809	ANDA	Shorla Oncology Inc.	81927-111	81927-111-01	1 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 50 mL in 1 VIAL, SINGLE-DOSE
NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	214809	ANDA	Shorla Oncology Inc.	81927-111	81927-111-06	6 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Mar 3, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	375MG/75ML (5MG/ML)
Approval Date:	Jul 16, 2025	TE:		RLD:	No

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