Active substance
Sodium tetradecyl
- US FDA 3
- Health Canada 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SOTRADECOL | 20MG/2ML (10MG/ML); 60MG/2ML (30MG/ML) | injectable · injection | MYLAN INSTITUTIONAL | Prescription | 12 Nov 2004 |
| SODIUM TETRADECYL SULFATE | 60MG/2ML (30MG/ML) | injectable · injection | HIKMA PHARMS | Prescription | 9 Dec 2019 |
| SOTRADECOL | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | ELKINS SINN | Discontinued | 13 Aug 1946 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| TROMBOJECT 1% | 00511234 | 10 MG / ML | SOLUTION · INTRAVENOUS | OMEGA LABORATORIES LIMITED |
| TROMBOJECT 3% | 00511226 | 30 MG / ML | SOLUTION · INTRAVENOUS | OMEGA LABORATORIES LIMITED |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.