Active substance
Colistin
- US FDA 1
- Health Canada 3
- WHO EML 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| COLY-MYCIN S | EQ 25MG BASE/5ML | suspension · oral | PARKE DAVIS | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| COLISTIMETHATE FOR INJECTION U.S.P. | 02244849 | 150 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | STERIMAX INC |
| COLISTIMETHATE FOR INJECTION, USP | 02403544 | 150 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | FRESENIUS KABI CANADA LTD |
| COLY-MYCIN M | 00476420 | 150 MG / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUS | SEARCHLIGHT PHARMA INC |
WHO WHO Model List of Essential Medicines (2025)
- 6.2.3. Reserve group antibiotics · complementary
Carbapenem resistant Acinetobacter baumannii; Carbapenem-resistant Pseudomonas aeruginosa; Other carbapenem resistant Enterobacterales; Carbapenem resistant Klebsiella pneumoniae; Carbapenem resistant Escherichia coli
Parenteral > General injections > unspecified: 1 million IU in vial (as colistemethate sodium) (equivalent to 34 mg colistin base activity)
Safety signals and safety-related labeling changes
- US FDA 5 Jan 2019 COLY-MYCIN S — safety-related labeling change
Labeling sections changed: Adverse Reactions
Combinations containing Colistin
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.