Exelderm

Treats tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton…. NDA 18738, held by Journey. Sulconazole Nitrate.

As of Nov 13, 2026, NDA 18738 (Exelderm), held by Journey, was first approved by FDA on Aug 30, 1985, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 30, 1985
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 30, 1985	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Exelderm1% · solution;topical	Sulconazole Nitrate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


May 19, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 8, 2009	Supplement 9Manufacturing · Standard review	Approved	Letter Label
May 30, 2003	Supplement 7Labeling · Standard review	Approved	Label Letter
Oct 19, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 22, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 8, 1991	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 14, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 20, 1990	Supplement 2Labeling	Approved	None posted
Jul 20, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 18, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 30, 1985	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 18738
Drugs@FDA: Overview at FDA
Company: Journey Medical

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