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

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Julphar
Chinese Patent Office
Farmers Insurance
Chubb
McKinsey
AstraZeneca
Accenture

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040743

« Back to Dashboard

NDA 040743 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 040743
Tradename:FLUOROURACIL
Applicant:Accord Hlthcare
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040743
Medical Subject Heading (MeSH) Categories for 040743
Suppliers and Packaging for NDA: 040743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040743 ANDA Accord Healthcare, Inc. 16729-276 N 16729-276-67
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040743 ANDA Accord Healthcare, Inc. 16729-276 N 16729-276-68

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/20ML (50MG/ML)
Approval Date:Apr 26, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/10ML (50MG/ML)
Approval Date:Apr 26, 2007TE:APRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Dow
Teva
Queensland Health
Boehringer Ingelheim
Julphar
Deloitte
Fish and Richardson
Baxter

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.