Is Dexamethasone + Tobramycin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Dexamethasone + Tobramycin, including OPTIDEX-T STERILE OPHTALMIC SUSP (0.3,0.1 %,%, Eye drops, suspension, SAR 19.95); TOBRADEX EYE DROPS (0.3,0.1 %,%, Eye drops, suspension, SAR 21.00); TOBRADEX EYE OINT (0.3,0.1 %,%, Eye ointment, SAR 20.40); Toycin (3,1 mg,mg, Eye drops, suspension, SAR 18.90).

Is Dexamethasone + Tobramycin approved by the US FDA?

Drugs@FDA lists 6 application product lines for Dexamethasone + Tobramycin, including TOBRADEX (Prescription); TOBRADEX (Prescription); TOBRAMYCIN AND DEXAMETHASONE (Prescription); TOBRADEX ST (Prescription); TOBRAMYCIN AND DEXAMETHASONE (Prescription).

Active substances

Dexamethasone + Tobramycin

SFDA 4
US FDA 6
Health Canada 2
US price lines 1
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OPTIDEX-T STERILE OPHTALMIC SUSP	0.3,0.1 %,%	Eye drops, suspension · Ophthalmic use	1 Dropper Container	SAR 19.95	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
TOBRADEX EYE DROPS	0.3,0.1 %,%	Eye drops, suspension · Ocular use	1 Dropper Container	SAR 21.00	NCE · Prescription	NOVARTIS PHARMA AG	Valid
TOBRADEX EYE OINT	0.3,0.1 %,%	Eye ointment · Ocular use	1 Tube	SAR 20.40	NCE · Prescription	NOVARTIS PHARMA AG	Valid
Toycin	3,1 mg,mg	Eye drops, suspension · Ocular use	1 Dropper Container	SAR 18.90	Generic · Prescription	Advanced Pharmaceutical Industries	Valid

Indications — CHI Daman Drug Formulary

OTITIS EXTERNA

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

Product	Strength	Form · route	Applicant	Status	First approved
TOBRADEX	0.1%;0.3%	suspension/drops · ophthalmic	SANDOZ	Prescription	18 Aug 1988
TOBRADEX	0.1%;0.3%	ointment · ophthalmic	NOVARTIS	Prescription	28 Sep 1988
TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	suspension/drops · ophthalmic	BAUSCH AND LOMB INC	Prescription	27 Oct 1999
TOBRADEX ST	0.05%;0.3%	suspension/drops · ophthalmic	HARROW EYE	Prescription	13 Feb 2009
TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	suspension/drops · ophthalmic	PADAGIS US	Prescription	11 Feb 2022
TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	suspension/drops · ophthalmic	AMNEAL	Discontinued	15 Jul 2021

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TOBRADEX	00778907	0.3 % / W/V; 0.1 % / W/V	SUSPENSION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
TOBRADEX	00778915	0.1 % / W/W; 0.3 % / W/W	OINTMENT · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TOBRADEX ST 0.3-0.05% EYE DROP	$46.63243	per ML	23 Sep 2026
NHS Drug Tariff	Dexamethasone 0.1% / Tobramycin 0.3% eye drops	£5.37	5 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

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.