Regulatory PathRegulatory requirements compared

Active substance

Ciclopirox

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LOPROX0.77%cream · topicalEUROFARMAPrescription30 Dec 1982
LOPROX0.77%suspension · topicalEUROFARMAPrescription30 Dec 1988
CICLOPIROX0.77%suspension · topicalFOUGERA PHARMSPrescription6 Aug 2004
CICLOPIROX0.77%cream · topicalFOUGERA PHARMSPrescription29 Dec 2004
CICLOPIROX0.77%cream · topicalSUN PHARMA CANADAPrescription12 Apr 2005
CICLOPIROX0.77%cream · topicalPADAGIS ISRAELPrescription3 Mar 2006
CICLOPIROX0.77%suspension · topicalPADAGIS ISRAELPrescription15 Dec 2006
CICLOPIROX8%solution · topicalPADAGIS USPrescription18 Sep 2007
CICLOPIROX8%solution · topicalENCUBEPrescription18 Sep 2007
CICLOPIROX8%solution · topicalCHARTWELL RXPrescription18 Sep 2007
CICLOPIROX8%solution · topicalRISINGPrescription18 Sep 2007
CICLOPIROX8%solution · topicalACELLAPrescription18 Sep 2007
CICLOPIROX0.77%gel · topicalFOUGERA PHARMSPrescription10 Jun 2008
CICLOPIROX0.77%gel · topicalPADAGIS USPrescription7 Jan 2009
CICLOPIROX0.77%cream · topicalGLENMARK PHARMSPrescription10 Nov 2009
CICLOPIROX1%shampoo · topicalACTAVIS MID ATLANTICPrescription24 Nov 2009
CICLOPIROX1%shampoo · topicalPADAGIS USPrescription16 Feb 2010
CICLOPIROX1%shampoo · topicalFOUGERA PHARMSPrescription25 May 2010
CICLOPIROX0.77%cream · topicalCOSETTE PHARMS NCPrescription20 Dec 2010
CICLOPIROX1%shampoo · topicalSUN PHARMA CANADAPrescription23 Feb 2011
CICLOPIROX0.77%gel · topicalGLENMARK PHARMSPrescription29 Feb 2012
CICLOPIROX1%shampoo · topicalENCUBEPrescription5 Apr 2018
CICLOPIROX0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**gel · topicalALVOGENDiscontinued21 Jul 1997
PENLAC8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · topicalVALEANT BERMUDADiscontinued17 Dec 1999
LOPROX1%shampoo · topicalBAUSCHDiscontinued28 Feb 2003

7 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-CICLOPIROX022989538 % / W/WSOLUTION · TOPICALAPOTEX INC
TARO-CICLOPIROX023532888 % / W/WSOLUTION · TOPICALTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCICLOPIROX 0.77% CREAM$0.20766per GM23 Sep 2026
US NADACCICLOPIROX 0.77% CREAM$0.1025per GM23 Sep 2026
US NADACCICLOPIROX 0.77% CREAM$0.16869per GM23 Sep 2026
US NADACCICLOPIROX 0.77% GEL$0.76886per GM23 Sep 2026
US NADACCICLOPIROX 0.77% GEL$0.84751per GM23 Sep 2026
US NADACCICLOPIROX 0.77% GEL$0.78726per GM23 Sep 2026
US NADACCICLOPIROX 0.77% TOPICAL SUSP$0.7215per ML23 Sep 2026
US NADACCICLOPIROX 0.77% TOPICAL SUSP$0.80936per ML23 Sep 2026
US NADACCICLOPIROX 1% SHAMPOO$0.2108per ML23 Sep 2026
US NADACCICLOPIROX 8% SOLUTION$1.15412per 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.

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.