KETOCONAZOLE
Details
- Status
- Prescription
- First Approved
- 1999-06-15
- Routes
- ORAL, TOPICAL
- Dosage Forms
- TABLET, CREAM, SHAMPOO, AEROSOL, FOAM
Companies
KETOCONAZOLE Approval History
What KETOCONAZOLE Treats
1 indicationsKETOCONAZOLE is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- 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.
KETOCONAZOLE FDA Label Details
ProIndications & Usage
FDA Label (PDF)INDICATIONS & USAGE Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.