Treats tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by…. NDA 18737, held by Journey. Sulconazole Nitrate.
As of Nov 13, 2026, NDA 18737 (Exelderm), held by Journey, was first approved by FDA on Feb 28, 1989, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 1989 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exelderm1% · cream;topical | Sulconazole Nitrate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 30, 2003 | Supplement 3Labeling · Standard review | Approved | |
| Oct 19, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 13, 1991 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1989 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
