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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Harvard Business School
Dow
Medtronic
Baxter
QuintilesIMS
US Department of Justice
McKesson
Chinese Patent Office

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091299

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NDA 091299 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 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. Fifteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 091299
Tradename:FLUOROURACIL
Applicant:Sandoz
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091299
Medical Subject Heading (MeSH) Categories for 091299
Suppliers and Packaging for NDA: 091299
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 091299 ANDA Sandoz Inc 66758-054 N 66758-054-01
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 091299 ANDA Sandoz Inc 66758-054 N 66758-054-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2.5GM/50ML (50MG/ML)
Approval Date:May 2, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5GM/100ML (50MG/ML)
Approval Date:May 2, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
QuintilesIMS
Deloitte
Covington
Teva
Moodys
Medtronic
Citi
Federal Trade Commission

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