Last Updated: September 28, 2026

Details for New Drug Application (NDA): 078610

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NDA 078610 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Caplin One Labs, Extrovis, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Rising, and Sagent Pharms Inc, and is included in twelve NDAs. It is available from six suppliers. Additional details are available on the FLUDARABINE PHOSPHATE profile page.

The generic ingredient in FLUDARABINE PHOSPHATE is fludarabine phosphate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

Summary for 078610

Tradename:	FLUDARABINE PHOSPHATE
Applicant:	Actavis Totowa
Ingredient:	fludarabine phosphate
Patents:	0

Pharmacology for NDA: 078610

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 078610

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078610	ANDA	Actavis Pharma, Inc.	45963-609	45963-609-55	1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/VIAL
Approval Date:	Feb 11, 2009	TE:	AP	RLD:	No

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