Regulatory PathRegulatory requirements compared

Active substance

Gatifloxacin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
TYMER 0.3% EYE DROP0.3 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 28.35Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
Tymer0.5 %Eye drops, solution · Ophthalmic use1 BottleSAR 47.25Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ZYMAXID 0.5% eye drops solution0.5 %Ophthalmic solution · Ophthalmic use1 Dropper ContainerSAR 28.35NCE · PrescriptionAbbVie IncValid
ZYMAR 0.3% OPHTHALMIC SOLUTION0.3 %Ophthalmic solution · Ophthalmic use1 Dropper ContainerSAR 28.35Generic · PrescriptionALLERGAN PHARMACEUTICALS LTDWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANTIBIOTIC SURGICAL PROPHYLAXIS; MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE - CHLAMYDIAL CONJUNCTIVITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
ZYMAXID0.5%solution/drops · ophthalmicABBVIEPrescription18 May 2010
GATIFLOXACIN0.5%solution/drops · ophthalmicSANDOZPrescription11 Jul 2016
GATIFLOXACIN0.5%solution/drops · ophthalmicCAPLINPrescription3 Nov 2021
ZYMAR0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution/drops · ophthalmicALLERGANDiscontinued28 Mar 2003
GATIFLOXACIN0.3%solution/drops · ophthalmicAPOTEX INCDiscontinued19 Aug 2011
GATIFLOXACIN0.5%solution/drops · ophthalmicLUPINDiscontinued28 Aug 2013
GATIFLOXACIN0.5%solution/drops · ophthalmicHIKMA PHARMSDiscontinued3 Sep 2014
GATIFLOXACIN0.5%solution/drops · ophthalmicRISINGDiscontinued8 Jun 2018

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP GATIFLOXACIN025332350.3 % / W/VSOLUTION · OPHTHALMICJAMP PHARMA CORPORATION
ZYMAR022572700.3 % / W/VSOLUTION · OPHTHALMICABBVIE CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACGATIFLOXACIN 0.5% EYE DROPS$8.8549per ML23 Sep 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.

Safety signals and safety-related labeling changes

  • US FDA 21 Mar 2017 ZYMAR — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 8 Sep 2016 ZYMAXID — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for gatifloxacin →

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.