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Generated: December 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040772

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NDA 040772 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 040772
Tradename:FLUOROURACIL
Applicant:Ebewe Pharma
Ingredient:fluorouracil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040772
Medical Subject Heading (MeSH) Categories for 040772
Suppliers and Packaging for NDA: 040772
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040772 ANDA Sandoz Inc 66758-044 66758-044-03 10 VIAL, SINGLE-USE in 1 CARTON (66758-044-03) > 10 mL in 1 VIAL, SINGLE-USE (66758-044-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/10ML (50MG/ML)
Approval Date:Aug 11, 2008TE:RLD:No

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Cerilliant
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