Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020038

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NDA 020038 describes FLUDARA, which is a drug marketed by Genzyme Corp, 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 thirteen NDAs. Additional details are available on the FLUDARA profile page.

The generic ingredient in FLUDARA 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 020038

Tradename:	FLUDARA
Applicant:	Genzyme Corp
Ingredient:	fludarabine phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 18, 1991	TE:		RLD:	Yes

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