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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Chinese Patent Office
Cerilliant
AstraZeneca
Covington
Citi
Harvard Business School
Mallinckrodt
UBS

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077524

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NDA 077524 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 077524

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

Pharmacology for NDA: 077524

Medical Subject Heading (MeSH) Categories for 077524

Suppliers and Packaging for NDA: 077524

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil CREAM;TOPICAL 077524 ANDA Rebel Distributors Corp 21695-829 21695-829-40 40 g in 1 TUBE (21695-829-40)
FLUOROURACIL fluorouracil CREAM;TOPICAL 077524 ANDA Physicians Total Care, Inc. 54868-6293 54868-6293-0 1 TUBE in 1 CARTON (54868-6293-0) > 40 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Apr 11, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Novartis
Julphar
McKesson
Healthtrust
Fuji
Colorcon
Dow
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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