Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Covington
Chinese Patent Office
Argus Health
Mallinckrodt
US Army
Johnson and Johnson
Healthtrust

Generated: September 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040278

« Back to Dashboard

NDA 040278 describes FLUOROURACIL, which is a drug marketed by Mayne Pharma, Mylan Pharms Inc, 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 eleven 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. Eighteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 040278
Tradename:FLUOROURACIL
Applicant:Fresenius Kabi Usa
Ingredient:fluorouracil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040278
Medical Subject Heading (MeSH) Categories for 040278
Suppliers and Packaging for NDA: 040278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040278 ANDA Fresenius Kabi USA, LLC 63323-117 63323-117-19 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-19) > 10 mL in 1 VIAL, SINGLE-DOSE
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040278 ANDA Fresenius Kabi USA, LLC 63323-117 63323-117-59 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-59) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/50ML (50MG/ML)
Approval Date:Sep 30, 1998TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML (50MG/ML)
Approval Date:Sep 30, 1998TE: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:

Moodys
Argus Health
Teva
Chinese Patent Office
Cipla
Baxter
Boehringer Ingelheim
Healthtrust
McKesson

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.