CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE (ciprofloxacin hydrochloride) · COSETTE PHARMS NC
Ciprofloxacin hydrochloride and hydrocortisone otic suspension is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .
Details
- Status
- Prescription
- First Approved
- 2025-11-10
- Routes
- OTIC
- Dosage Forms
- SUSPENSION/DROPS
Companies
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE Approval History
What CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE Treats
1 indicationsCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Otitis Externa
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00596453 results posted | NA_00010549 | Ph 4 | terminated | Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability |
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.
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE FDA Label Details
Indications & Usage
Ciprofloxacin hydrochloride and hydrocortisone otic suspension is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.