OTICAIR
Details
- Status
- Prescription
- First Approved
- 1996-08-28
- Routes
- OTIC
- Dosage Forms
- SUSPENSION/DROPS
Companies
OTICAIR Approval History
What OTICAIR Treats
10 indicationsOTICAIR is approved for 10 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin Irritation
- Inflammation
- Eczema
- Psoriasis
- Poison Ivy
- Poison Oak
- Poison Sumac
- Insect Bites
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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.
OTICAIR FDA Label Details
ProIndications & Usage
Uses • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.