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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 016831


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NDA 016831 describes EFUDEX, which is a drug marketed by Extrovis and is included in one NDA. It is available from two suppliers. 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. Twenty suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 016831
Tradename:EFUDEX
Applicant:Extrovis
Ingredient:fluorouracil
Patents:0
Pharmacology for NDA: 016831
Mechanism of ActionNucleic Acid Synthesis Inhibitors
Medical Subject Heading (MeSH) Categories for 016831
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
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 Bausch Health US, LLC 0187-3204 0187-3204-47 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE
EFUDEX fluorouracil SOLUTION;TOPICAL 016831 NDA Bausch Health US, LLC 0187-3204 0187-3204-47 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE

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:DISCNDosage:SOLUTION;TOPICALStrength5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD: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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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