Fluoroplex

NDA 16988, held by Chartwell Rx. Fluorouracil.

As of Nov 13, 2026, NDA 16988 (Fluoroplex), held by Chartwell Rx, was first approved by FDA on Aug 6, 1971, with 20 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1971
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Aug 6, 1971	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluoroplex1% · cream;topical	Fluorouracil	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Feb 28, 2022	Supplement 33Labeling · Standard review	Approved	Label Letter
Jul 25, 2016	Supplement 30Labeling · Standard review	Approved	Label Letter
Mar 1, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 29, 2016	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 18, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 1, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 30, 1998	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 30, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 8, 1992	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 28, 1987	Supplement 20Labeling	Approved	None posted
Jan 12, 1981	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 18, 1980	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 7, 1980	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 17, 1978	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 1, 1977	Supplement 14Labeling	Approved	None posted
Mar 2, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 6, 1976	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 9, 1976	Supplement 10Labeling	Approved	None posted
Dec 24, 1975	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 17, 1974	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 6, 1971	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16988
Drugs@FDA: Overview at FDA
Company: Chartwell RX

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters