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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040279

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NDA 040279 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 040279
Tradename:FLUOROURACIL
Applicant:Fresenius Kabi Usa
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040279
Medical Subject Heading (MeSH) Categories for 040279
Suppliers and Packaging for NDA: 040279
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040279 ANDA Fresenius Kabi USA, LLC 63323-117 N 63323-117-10
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040279 ANDA Fresenius Kabi USA, LLC 63323-117 N 63323-117-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/20ML (50MG/ML)
Approval Date:Sep 30, 1998TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/10ML (50MG/ML)
Approval Date:Sep 30, 1998TE:APRLD:No

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