CLOTRIMAZOLE
Details
- Status
- Prescription
- First Approved
- 1993-07-16
- Routes
- TOPICAL, ORAL, VAGINAL
- Dosage Forms
- CREAM, SOLUTION, TROCHE/LOZENGE
Companies
CLOTRIMAZOLE Approval History
What CLOTRIMAZOLE Treats
5 indicationsCLOTRIMAZOLE is approved for 5 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidiasis
- Tinea Versicolor
- Tinea Pedis
- Tinea Cruris
- Tinea Corporis
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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.
CLOTRIMAZOLE FDA Label Details
ProIndications & Usage
INDICATIONS & USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.