TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Details
- Status
- Prescription
- First Approved
- 1997-02-14
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
Companies
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Approval History
What TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Treats
3 indicationsTRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ocular Bacterial Infection
- Acute Bacterial Conjunctivitis
- Blepharoconjunctivitis
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.
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE FDA Label Details
ProIndications & Usage
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenza and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.