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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Accenture
QuintilesIMS
McKesson
Healthtrust
UBS
Queensland Health
Johnson and Johnson
Harvard Business School

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012209

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NDA 012209 describes FLUOROURACIL, which is a drug marketed by Mylan Pharms Inc, Spear Pharms, Taro, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marchar, Mylan Labs Ltd, Sagent Pharms, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Taro Pharm, and is included in thirty-one NDAs. It is available from twelve 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 012209
Tradename:FLUOROURACIL
Applicant:Spectrum Pharms
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 012209

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2.5GM/50ML (50MG/ML)
Approval Date:Jul 29, 2016TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Dow
Colorcon
US Army
Cerilliant
Julphar
Cipla
Fish and Richardson
Mallinckrodt

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