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Data updated: May 26, 2026

SOTRADECOL (sodium tetradecyl sulfate)

Cardiovascular Approved 1946-08-13

SOTRADECOL is indicated for the treatment of Varicose Veins.

Source: FDA Label • Viatris
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
79
Years on Market

Details

Status
Prescription
First Approved
1946-08-13
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Viatris ELKINS SINN
Active Ingredient: SODIUM TETRADECYL SULFATE

SOTRADECOL Approval History

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Original
New Indication
New Form
Label Update
44 FDA actions from 1946 to 2019
May 2019 SUPPL
Label · Labeling
Mar 2018 SUPPL
Label · Labeling
May 2008 SUPPL
Label · Labeling

What SOTRADECOL Treats

1 indications

SOTRADECOL is approved for 1 conditions since its original approval in 1946. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Varicose Veins
Source: FDA Label

SOTRADECOL Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

VARITHENA
PROVENSIS
2013 1 indic.
ASCLERA
CHEMISCH FBRK
2010 3 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SOTRADECOL

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ASCLERA
POLIDOCANOL
1 shared
CHEMISCH FBRK KRSSLR
Shared indications:
Varicose Veins
SODIUM TETRADECYL SULFATE
SODIUM TETRADECYL SULFATE
1 shared
Hikma
Shared indications:
Varicose Veins
VARITHENA
POLIDOCANOL
1 shared
PROVENSIS
Shared indications:
Varicose Veins
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Indications & Usage

SOTRADECOL is indicated for the treatment of Varicose Veins.

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Data Sources

FDA Approval: ANDA040541 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.