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Last Updated: December 12, 2025

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. 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. Twenty-one 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

Medical Subject Heading (MeSH) Categories for 016988

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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