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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215057

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NDA 215057 describes NELARABINE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, 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. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

Summary for 215057

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

Pharmacology for NDA: 215057

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Jun 2, 2023	TE:	AP	RLD:	No

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