DERMOTIC
Details
- Status
- Prescription
- First Approved
- 1988-02-03
- Routes
- OTIC
- Dosage Forms
- OIL/DROPS
DERMOTIC Approval History
What DERMOTIC Treats
1 indicationsDERMOTIC is approved for 1 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- External Otitis
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.
DERMOTIC FDA Label Details
ProIndications & Usage
FDA Label (PDF)DERMOTIC ® OIL is a corticosteroid indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. DermOtic ® Oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.