Is Dexamethasone + Neomycin + Polymyxin b registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Dexamethasone + Neomycin + Polymyxin b, including MAXITROL (6000,3500,1 IU/ml,IU/ml,mg/ml, Eye ointment, SAR 11.30); MAXITROL DROPS (6000,3500,1 IU/ml,IU/ml,mg/ml, Eye drops, suspension, SAR 11.55).

Is Dexamethasone + Neomycin + Polymyxin b approved by the US FDA?

Drugs@FDA lists 11 application product lines for Dexamethasone + Neomycin + Polymyxin b, including MAXITROL (Prescription); MAXITROL (Prescription); MAXITROL (Prescription); NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (Prescription); DEXASPORIN (Prescription).

Active substances

Dexamethasone + Neomycin + Polymyxin b

SFDA 4
US FDA 11
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
MAXITROL	6000,3500,1 IU/ml,IU/ml,mg/ml	Eye ointment · Ocular use	1 Tube	SAR 11.30	NCE · Prescription	NOVARTIS PHARMA AG	Valid
MAXITROL DROPS	6000,3500,1 IU/ml,IU/ml,mg/ml	Eye drops, suspension · Ocular use	1 Dropper Container	SAR 11.55	NCE · Prescription	NOVARTIS PHARMA AG	Valid
MAXITROL DROPS		Eye drops, suspension · Ophthalmic use	1 Dropper Container	SAR 16.30	NCE · Prescription	ALCON LABORATORIES	Withdrawn by MAH · Not Marketed
MAXITROL EYE OINT.		Eye ointment · Ophthalmic use	1 Tube	SAR 11.30	NCE · Prescription	ALCON COUVREUR	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	suspension/drops · ophthalmic	HARROW EYE	Prescription	6 Jun 1963
MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	ointment · ophthalmic	SANDOZ	Prescription	19 Jul 1963
MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	suspension/drops · ophthalmic	SANDOZ	Prescription	22 May 1984
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	ointment · ophthalmic	BAUSCH AND LOMB INC	Prescription	25 Jul 1994
DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	suspension/drops · ophthalmic	BAUSCH AND LOMB INC	Prescription	13 Sep 1995
DEXACIDIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	suspension/drops · ophthalmic	NOVARTIS	Discontinued	29 Oct 1984
DEXACIDIN	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	ointment · ophthalmic	NOVARTIS	Discontinued	22 Feb 1985
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	suspension/drops · ophthalmic	ALCON PHARMS LTD	Discontinued	17 Nov 1986
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	ointment · ophthalmic	PADAGIS US	Discontinued	31 Jul 1989
DEXASPORIN	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	ointment · ophthalmic	PHARMAFAIR	Discontinued
DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	suspension/drops · ophthalmic	PHARMAFAIR	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MAXITROL	00042676	0.1 % / W/V; 3.5 MG / ML; 6000 UNIT / ML	SUSPENSION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
MAXITROL	00358177	6000 UNIT / G; 0.1 % / W/W; 3.5 MG / G	OINTMENT · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC

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.