Regulatory PathRegulatory requirements compared

Active substance

Chloroprocaine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NESACAINE2%injectable · injectionFRESENIUS KABI USAPrescription11 Mar 1955
NESACAINE-MPF2%; 3%injectable · injectionFRESENIUS KABI USAPrescription11 Mar 1955
CHLOROPROCAINE HYDROCHLORIDE2%; 3%injectable · injectionHIKMA PHARMSPrescription9 Sep 1998
IHEEZO3%gel · ophthalmicHARROW EYEPrescription27 Sep 2022
NESACAINE1%injectable · injectionFRESENIUS KABI USADiscontinued11 Mar 1955
NESACAINE-MPF2%; 3%injectable · injectionFRESENIUS KABI USADiscontinued11 Mar 1955
CHLOROPROCAINE HYDROCHLORIDE3%injectable · injectionHOSPIRADiscontinued16 Apr 1982
CHLOROPROCAINE HYDROCHLORIDE2%injectable · injectionHOSPIRADiscontinued16 Apr 1982
CLOROTEKAL50MG/5ML (10MG/ML)solution · intrathecalB BRAUN MEDICALDiscontinued26 Sep 2017

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CLOROTEKAL0255106310 MG / MLSOLUTION · INTRATHECALB. BRAUN MELSUNGEN AG

Safety signals and safety-related labeling changes

All safety entries for chloroprocaine →

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.