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Queensland Health
Farmers Insurance
Chinese Patent Office
Colorcon
Moodys
Fuji
Chubb
Cipla
AstraZeneca

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078544

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NDA 078544 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Llc, Actavis Totowa, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, 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 078544
Tradename:FLUDARABINE PHOSPHATE
Applicant:Fresenius Kabi Usa
Ingredient:fludarabine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078544
Suppliers and Packaging for NDA: 078544
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078544 ANDA APP Pharmaceuticals, LLC 63323-196 N 63323-196-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Oct 15, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Cerilliant
Federal Trade Commission
Dow
Accenture
Cantor Fitzgerald
Colorcon
US Department of Justice
Teva

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