BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Teva
Farmers Insurance
Julphar
Novartis
Johnson and Johnson
QuintilesIMS
UBS
Harvard Business School
Daiichi Sankyo
US Department of Justice

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040334

« Back to Dashboard

NDA 040334 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 040334
Tradename:FLUOROURACIL
Applicant:Teva Pharms Usa
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040334
Medical Subject Heading (MeSH) Categories for 040334
Suppliers and Packaging for NDA: 040334
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040334 ANDA Teva Parenteral Medicines, Inc. 0703-3018 0703-3018-12 5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0703-3018-12) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0703-3018-11)
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040334 ANDA Teva Parenteral Medicines, Inc. 0703-3019 0703-3019-12 5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0703-3019-12) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0703-3019-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/50ML (50MG/ML)
Approval Date:Feb 25, 2000TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML (50MG/ML)
Approval Date:Feb 25, 2000TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
US Army
Julphar
Queensland Health
Accenture
AstraZeneca
Farmers Insurance
Dow
Citi

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.

botpot