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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021877

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NDA 021877 describes ARRANON, which is a drug marketed by Sandoz and is included in one NDA. It is available from two suppliers. Additional details are available on the ARRANON profile page.

The generic ingredient in ARRANON 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 021877

Tradename:	ARRANON
Applicant:	Sandoz
Ingredient:	nelarabine
Patents:	0

Pharmacology for NDA: 021877

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 021877

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877	NDA	Novartis Pharmaceuticals Corporation	0078-0683	0078-0683-61	50 mL in 1 VIAL (0078-0683-61)
ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877	NDA	Sandoz Inc	66758-165	66758-165-86	6 VIAL in 1 CARTON (66758-165-86) / 50 mL in 1 VIAL (66758-165-94)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/50ML (5MG/ML)
Approval Date:	Oct 28, 2005	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021877

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,424,295	⤷ Get Started Free
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,821,236	⤷ Get Started Free
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,747,472	⤷ Get Started Free
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,492,897	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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