SULFACETAMIDE SODIUM
Details
- Status
- Prescription
- First Approved
- 1971-12-22
- Routes
- OPHTHALMIC, TOPICAL
- Dosage Forms
- OINTMENT, LOTION, SOLUTION/DROPS
Companies
SULFACETAMIDE SODIUM Approval History
What SULFACETAMIDE SODIUM Treats
3 indicationsSULFACETAMIDE SODIUM is approved for 3 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Conjunctivitis
- Ocular Infections
- Trachoma
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Active Pipeline
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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.
SULFACETAMIDE SODIUM FDA Label Details
ProIndications & Usage
Sulfacetamide Sodium Ophthalmic Solution, USP 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa . A significant percentage of staphylococcal isolates...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.