TheraRadar
Data updated: May 26, 2026

EXELDERM (sulconazole nitrate)

Infectious Disease Approved 1985-08-30

EXELDERM is indicated for the treatment of Tinea Pedis; Tinea Cruris; Tinea Corporis; Tinea Versicolor.

Source: FDA Label • JOURNEY
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1985-08-30
Routes
TOPICAL
Dosage Forms
CREAM, SOLUTION

Companies

JOURNEY
Active Ingredient: SULCONAZOLE NITRATE

EXELDERM Approval History

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Original
New Indication
New Form
Label Update
16 FDA actions from 1985 to 2014
May 2014 SUPPL
Mfg · Manufacturing (CMC)
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)
Jul 2009 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What EXELDERM Treats

4 indications

EXELDERM 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
Source: FDA Label

EXELDERM Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CLOTIC
CARWIN PHARM
2025 3 indic.
STERITALC
NOVATECH SA
2017 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to EXELDERM

3 of 19

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CLOTRIMAZOLE
CLOTRIMAZOLE
4 shared
Hikma
Shared indications:
Tinea VersicolorTinea PedisTinea Cruris +1 more
OXICONAZOLE NITRATE
OXICONAZOLE NITRATE
4 shared
SUN PHARMA CANADA
Shared indications:
Tinea PedisTinea CrurisTinea Corporis +1 more
CLOTIC
CLOTRIMAZOLE
3 shared
CARWIN PHARM ASSOC
Shared indications:
Tinea PedisTinea CrurisTinea Corporis
View all 19 similar drugs Pro
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Indications & Usage

FDA Label (PDF)

EXELDERM is indicated for the treatment of Tinea Pedis; Tinea Cruris; Tinea Corporis; Tinea Versicolor.

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Data Sources

FDA Approval: NDA018737 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.