CETRAXAL (ciprofloxacin hydrochloride)
CETRAXAL is indicated for the treatment of Bacterial Conjunctivitis.
Details
- Status
- Prescription
- First Approved
- 2009-05-01
- Routes
- OTIC
- Dosage Forms
- SOLUTION/DROPS
CETRAXAL Approval History
What CETRAXAL Treats
1 indicationsCETRAXAL is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Conjunctivitis
CETRAXAL 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.
CETRAXAL FDA Label Details
Indications & Usage
FDA Label (PDF)CETRAXAL is indicated for the treatment of Bacterial Conjunctivitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.