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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089508

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NDA 089508 describes FLUOROURACIL, which is a drug marketed by Mayne Pharma, Mylan, Taro, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marchar, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa, and is included in thirty-one NDAs. It is available from ten suppliers. Additional details are available on the FLUOROURACIL profile page.

The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 089508
Tradename:FLUOROURACIL
Applicant:Bedford
Ingredient:fluorouracil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 089508

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Jan 26, 1988TE:RLD:No

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