SOTRADECOL
Details
- Status
- Prescription
- First Approved
- 1946-08-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SOTRADECOL Approval History
What SOTRADECOL Treats
1 indicationsSOTRADECOL is approved for 1 conditions since its original approval in 1946. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Varicose Veins
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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.
SOTRADECOL FDA Label Details
ProIndications & Usage
Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.