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Data updated: Mar 10, 2026

CLOTRIMAZOLE

CLOTRIMAZOLE
Infectious Disease Approved 1993-07-16
13
Indications
--
Phase 3 Trials
32
Years on Market

Details

Status
Prescription
First Approved
1993-07-16
Routes
TOPICAL, ORAL, VAGINAL
Dosage Forms
CREAM, SOLUTION, TROCHE/LOZENGE

CLOTRIMAZOLE Approval History

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What CLOTRIMAZOLE Treats

5 indications

CLOTRIMAZOLE 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
Source: FDA Label

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Completed studies with published results, ranked by significance

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Trial Timeline

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.

CLOTRIMAZOLE FDA Label Details

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Indications & 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.