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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Queensland Health
Mallinckrodt
Boehringer Ingelheim
Baxter
Federal Trade Commission
AstraZeneca
Fuji
McKinsey

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040333

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NDA 040333 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 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 040333

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040333

Medical Subject Heading (MeSH) Categories for 040333

Suppliers and Packaging for NDA: 040333

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040333 ANDA Teva Parenteral Medicines, Inc. 0703-3015 0703-3015-13 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-3015-13) > 10 mL in 1 VIAL, SINGLE-DOSE (0703-3015-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/10ML (50MG/ML)
Approval Date:Jan 27, 2000TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Cipla
Farmers Insurance
AstraZeneca
Cantor Fitzgerald
Daiichi Sankyo
Harvard Business School
Accenture
Chinese Patent Office

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