Is Polymyxin b + Trimethoprim registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Polymyxin b + Trimethoprim.

Is Polymyxin b + Trimethoprim approved by the US FDA?

Drugs@FDA lists 5 application product lines for Polymyxin b + Trimethoprim, including TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (Prescription); TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (Prescription); TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (Prescription); TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (Prescription); POLYTRIM (Discontinued).

Active substances

Polymyxin b + Trimethoprim

SFDA 1
US FDA 5
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OFTALMOTRIM EYE DROPS		Eye drops · Ocular use	1 Dropper Container	SAR 10.70	NCE · Prescription	ALCON CUSI	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Prescription	14 Feb 1997
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	solution/drops · ophthalmic	SANDOZ	Prescription	13 Apr 1998
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	solution/drops · ophthalmic	EPIC PHARMA LLC	Prescription	17 Dec 1998
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Prescription	5 Aug 2024
POLYTRIM	10,000 UNITS/ML;EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution/drops · ophthalmic	ALLERGAN	Discontinued	20 Oct 1988

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SANDOZ POLYTRIMETHOPRIM	02239234	10000 UNIT / ML; 1 MG / ML	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED

Components

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.