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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016831

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NDA 016831 describes EFUDEX, which is a drug marketed by Valeant Pharm Intl and is included in one NDA. It is available from one supplier. Additional details are available on the EFUDEX profile page.

The generic ingredient in EFUDEX is fluorouracil. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 016831
Tradename:EFUDEX
Applicant:Valeant Pharm Intl
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 016831
Medical Subject Heading (MeSH) Categories for 016831
Suppliers and Packaging for NDA: 016831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EFUDEX fluorouracil CREAM;TOPICAL 016831 NDA Valeant Pharmaceuticals North America LLC 0187-3204 N 0187-3204-47
EFUDEX fluorouracil SOLUTION;TOPICAL 016831 NDA Valeant Pharmaceuticals North America LLC 0187-3204 N 0187-3204-47

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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