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Generated: August 21, 2018

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Details for New Drug Application (NDA): 077790

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NDA 077790 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Sagent Pharms, and Sandoz, and is included in eleven NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
Summary for 077790
Tradename:FLUDARABINE PHOSPHATE
Applicant:Hospira
Ingredient:fludarabine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077790
Suppliers and Packaging for NDA: 077790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 077790 ANDA Hospira, Inc. 61703-344 N 61703-344-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Apr 6, 2007TE:APRLD:No

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