Regulatory PathRegulatory requirements compared

Active substances

Neomycin + Polymyxin b

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
STATROL OPHTHALMIC OINTMENTEye ointment · Ocular use1 TubeSAR 11.60NCE · PrescriptionALCON COUVREURWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
NEOSPORIN G.U. IRRIGANTEQ 800MG BASE/20ML;4,000,000 UNITS/20ML (EQ 40MG BASE/ML;200,000 UNITS/ML)solution · irrigationMONARCH PHARMSPrescription28 Jun 1966
NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLsolution · irrigationXGEN PHARMSPrescription31 Jan 2006
NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLsolution · irrigationXGEN PHARMSPrescription31 Jan 2006
NEOSPORIN G.U. IRRIGANTEQ 40MG BASE/ML;200,000 UNITS/MLsolution · irrigationMONARCH PHARMSDiscontinued28 Jun 1966
STATROLEQ 3.5MG BASE/GM;10,000 UNITS/GMointment · ophthalmicALCONDiscontinued12 Mar 1974
STATROLEQ 3.5MG BASE/ML;16,250 UNITS/MLsolution/drops · ophthalmicALCONDiscontinued12 Mar 1974
STATROLEQ 3.5MG BASE/ML;16,250 UNITS/MLsolution/drops · ophthalmicALCONDiscontinued30 Nov 1984
NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLsolution · irrigationWATSON LABSDiscontinued8 Apr 1986
NEOSPORINEQ 3.5MG BASE/GM;10,000 UNITS/GMcream · topicalGLAXOSMITHKLINEDiscontinued

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.