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Deloitte
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US Department of Justice
Fuji
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Chinese Patent Office
US Army

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077524

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NDA 077524 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 077524
Tradename:FLUOROURACIL
Applicant:Spear Pharms
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077524
Medical Subject Heading (MeSH) Categories for 077524
Suppliers and Packaging for NDA: 077524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROURACIL fluorouracil CREAM;TOPICAL 077524 ANDA Rebel Distributors Corp 21695-829 E 21695-829-40
FLUOROURACIL fluorouracil CREAM;TOPICAL 077524 ANDA Physicians Total Care, Inc. 54868-6293 E 54868-6293-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Apr 11, 2008TE:ABRLD:No

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