COLY-MYCIN S
Details
- Status
- Prescription
- First Approved
- 1962-05-17
- Routes
- OTIC, ORAL
- Dosage Forms
- SUSPENSION/DROPS, SUSPENSION
Companies
COLY-MYCIN S Approval History
What COLY-MYCIN S Treats
1 indicationsCOLY-MYCIN S is approved for 1 conditions since its original approval in 1962. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Infection
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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.
COLY-MYCIN S FDA Label Details
ProIndications & Usage
FDA Label (PDF)Cortisporin ® TC Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.