EXELDERM
Details
- Status
- Prescription
- First Approved
- 1985-08-30
- Routes
- TOPICAL
- Dosage Forms
- CREAM, SOLUTION
EXELDERM Approval History
What EXELDERM Treats
4 indicationsEXELDERM is approved for 4 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tinea Pedis
- Tinea Cruris
- Tinea Corporis
- Tinea Versicolor
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EXELDERM FDA Label Details
ProIndications & Usage
FDA Label (PDF)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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.