Fluoroplex

NDA 16765, held by Elorac. Fluorouracil.

As of Nov 13, 2026, NDA 16765 (Fluoroplex), held by Elorac, was first approved by FDA on Jul 31, 1970, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1970
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 31, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluoroplex1% · solution;topical	Fluorouracil	Discontinued

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 30, 1998	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 30, 1997	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 8, 1992	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 28, 1987	Supplement 21Labeling	Approved	None posted
Nov 12, 1986	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 16, 1982	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 13, 1982	Supplement 23Manufacturing · Standard review	Approved	None posted
May 13, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
May 15, 1981	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 12, 1981	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 18, 1980	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 23, 1979	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 16, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 17, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 15, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 3, 1976	Supplement 11Labeling	Approved	None posted
Jul 1, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 31, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16765
Drugs@FDA: Overview at FDA
Company: Elorac

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