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Generated: April 21, 2018

DrugPatentWatch Database Preview

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, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, and Sandoz, and is included in twelve NDAs. Additional details are available on the FLUDARA profile page.

The generic ingredient in FLUDARA 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 020038
Tradename:FLUDARA
Applicant:Genzyme Corp
Ingredient:fludarabine phosphate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 18, 1991TE:RLD:Yes

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