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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200648

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NDA 200648 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 nine 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. Nine suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
Summary for 200648
Tradename:FLUDARABINE PHOSPHATE
Applicant:Mylan Labs Ltd
Ingredient:fludarabine phosphate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Oct 16, 2012TE:APRLD:No

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