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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 022137

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NDA 022137 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Rising, Sagent Pharms Inc, and Sandoz, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the FLUDARABINE PHOSPHATE profile page.

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

Summary for 022137

Tradename:	FLUDARABINE PHOSPHATE
Applicant:	Sandoz
Ingredient:	fludarabine phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/2ML (25MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 21, 2007	TE:		RLD:	Yes

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