Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220196

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NDA 220196 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 220196

Tradename:	FLUDARABINE PHOSPHATE
Applicant:	Hisun Pharm Hangzhou
Ingredient:	fludarabine phosphate
Patents:	0

Pharmacology for NDA: 220196

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 220196

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	220196	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-024	42658-024-01	1 VIAL, SINGLE-DOSE in 1 CARTON (42658-024-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/2ML (25MG/ML)
Approval Date:	Jul 23, 2026	TE:		RLD:	No

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