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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 016988


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NDA 016988 describes FLUOROPLEX, which is a drug marketed by Chartwell Rx and Elorac and is included in two NDAs. It is available from one supplier. Additional details are available on the FLUOROPLEX profile page.

The generic ingredient in FLUOROPLEX 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 016988
Tradename:FLUOROPLEX
Applicant:Chartwell Rx
Ingredient:fluorouracil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016988
Medical Subject Heading (MeSH) Categories for 016988
Suppliers and Packaging for NDA: 016988
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROPLEX fluorouracil CREAM;TOPICAL 016988 NDA Almirall, LLC 16110-812 16110-812-30 1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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