Last Updated: September 28, 2026

Details for New Drug Application (NDA): 203738

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NDA 203738 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 203738

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/2ML (25MG/ML)
Approval Date:	Feb 28, 2017	TE:		RLD:	No

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