Efudex

Treats multiple actinic or solar keratoses. NDA 16831, held by Extrovis. Fluorouracil.

As of Nov 14, 2026, NDA 16831 (Efudex), held by Extrovis, was first approved by FDA on Jul 29, 1970, with 45 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1970
Review: Standard
Supplements approved: 45
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Fluorouracil 5% Topical Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below

Date	Submission	Status	Documents
Jul 29, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Efudex2% · solution;topical	Fluorouracil	RxReference drug
Efudex5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;topical	Fluorouracil	DiscontinuedReference drug
Efudex5% · cream;topical	Fluorouracil	RxReference drug

All 46 submissions, including labeling and manufacturing supplements


Oct 14, 2021	Supplement 63Labeling · Standard review	Approved	Label Letter
Nov 4, 2015	Supplement 59Manufacturing · Standard review	Approved	None posted
Aug 18, 2015	Supplement 58Manufacturing · Standard review	Approved	None posted
May 6, 2015	Supplement 57Manufacturing · Standard review	Approved	None posted
Dec 12, 2013	Supplement 55Manufacturing · Standard review	Approved	None posted
Jul 2, 2013	Supplement 56Manufacturing · Standard review	Approved	None posted
May 10, 2006	Supplement 51Manufacturing	Approved	Letter
Oct 13, 2005	Supplement 49Labeling · Standard review	Approved	Letter Label
Jun 24, 2004	Supplement 47Labeling · Standard review	Approved	Letter Label
Apr 27, 2004	Supplement 46Manufacturing · Standard review	Approved	Letter
Nov 27, 2002	Supplement 43Manufacturing · Standard review	Approved	None posted
Aug 30, 2001	Supplement 42Manufacturing · Standard review	Approved	None posted
Jul 3, 2001	Supplement 41Manufacturing · Standard review	Approved	None posted
Jul 3, 2001	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 12, 2001	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 7, 2000	Supplement 37Manufacturing · Standard review	Approved	None posted
Jul 7, 2000	Supplement 36Manufacturing · Standard review	Approved	None posted
Jun 20, 2000	Supplement 38Manufacturing · Standard review	Approved	None posted
Apr 5, 2000	Supplement 35Manufacturing · Standard review	Approved	Review
Nov 2, 1998	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 18, 1997	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 21, 1995	Supplement 29Labeling	Approved	None posted
Aug 5, 1993	Supplement 31Manufacturing · Standard review	Approved	Review
Mar 4, 1993	Supplement 30Manufacturing · Standard review	Approved	Review
Nov 30, 1988	Supplement 28Manufacturing · Standard review	Approved	Review
Mar 26, 1987	Supplement 17Labeling	Approved	None posted
Nov 14, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 10, 1985	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 14, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 13, 1984	Supplement 24Manufacturing · Standard review	Approved	None posted
May 4, 1984	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 12, 1983	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 12, 1983	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 14, 1983	Supplement 20Manufacturing · Standard review	Approved	None posted
May 14, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 10, 1982	Supplement 18Labeling	Approved	None posted
Dec 18, 1979	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 23, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 21, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 14, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 14, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 30, 1975	Supplement 8Manufacturing · Standard review	Approved	Review
May 7, 1975	Supplement 11Manufacturing · Standard review	Approved	Review
May 7, 1975	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 19, 1974	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 29, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16831
Drugs@FDA: Overview at FDA
Company: Extrovis

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