Regulatory PathRegulatory requirements compared

Active substances

Ciprofloxacin + Dexamethasone

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CIPRODEX0.3%;0.1%suspension/drops · oticSANDOZPrescription18 Jul 2003
CIPROFLOXACIN AND DEXAMETHASONE0.3%;0.1%suspension/drops · oticDR REDDYSPrescription10 Aug 2020
CIPROFLOXACIN AND DEXAMETHASONE0.3%;0.1%suspension/drops · oticSUN PHARMPrescription30 Aug 2022
CIPROFLOXACIN AND DEXAMETHASONE0.3%;0.1%suspension/drops · oticSENTISSPrescription9 Jun 2023
CIPROFLOXACIN AND DEXAMETHASONE0.3%;0.1%suspension/drops · oticAMNEALPrescription22 Mar 2024
CIPROFLOXACIN AND DEXAMETHASONE0.3%;0.1%suspension/drops · oticUPSHER SMITH LABSPrescription6 Jan 2026

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CIPRODEX022527160.3 % / W/V; 0.1 % / W/VSUSPENSION · OTICNOVARTIS PHARMACEUTICALS CANADA INC
SANDOZ CIPROFLOXACIN / DEXAMETHASONE025068820.3 % / W/V; 0.1 % / W/VSUSPENSION · OTICSANDOZ CANADA INCORPORATED
TARO-CIPROFLOXACIN/DEXAMETHASONE024819010.3 % / W/V; 0.1 % / W/VSUSPENSION · OTICTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffCiprofloxacin 0.3% / Dexamethasone 0.1% ear drops£6.125 ml1 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.