Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078393

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NDA 078393 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 078393

Tradename:	FLUDARABINE PHOSPHATE
Applicant:	Fresenius Kabi Usa
Ingredient:	fludarabine phosphate
Patents:	0

Pharmacology for NDA: 078393

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 078393

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078393	ANDA	Fresenius Kabi USA, LLC	63323-192	63323-192-02	1 VIAL in 1 BOX (63323-192-02) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/2ML (25MG/ML)
Approval Date:	Oct 15, 2007	TE:	AP1	RLD:	No

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