Regulatory PathRegulatory requirements compared

Active substances

Gramicidin + Neomycin + Polymyxin b

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
POLYSPECTRAN EYE EAR DROPS7500,3500,0.02 IU/ml,IU/ml,mg/mlEye drops · Auricular use1 BottleSAR 11.20NCE · PrescriptionDR. THILO LABORATORIESWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicBAUSCH AND LOMB INCPrescription31 Jan 1996
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicSCIEGEN PHARMSPrescription28 Oct 2005
NEOSPORIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicMONARCH PHARMSDiscontinued3 Jul 1968
NEO-POLYCIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicDOW PHARMDiscontinued
NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicPHARMAFAIRDiscontinued
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicWATSON LABSDiscontinued
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLsolution/drops · ophthalmicIPHARMDiscontinued

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.