Regulatory PathRegulatory requirements compared

Active substance

Clobetasol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CLOBEDERM0.05 %Cream · Topical1 TubeSAR 7.55Generic · PrescriptionRIYADH PHARMAValid
CLODERM 0.05% CREAM0.05 %Cream · Topical1 TubeSAR 5.95Generic · PrescriptionUNITED PHARMACEUTICAL CO.Valid
CLODERM 0.05% OINTMENT0.05 %Ointment · Topical1 TubeSAR 5.95Generic · PrescriptionUNITED PHARMACEUTICAL CO.Valid
DERMAMED 0.05% OINTMENT0.05 %Ointment · Topical1 TubeSAR 6.20Generic · PrescriptionMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESValid
DERMOVATE 0.05% SCALP APPLICATION0.05 %Scalp solution · Topical1 BottleSAR 17.00NCE · PrescriptionGLAXO SAUDI ARABIAValid
DERMOVATE CREAM 0.05%0.05 %Cream · Topical1 TubeSAR 9.45Generic · PrescriptionGLAXO SAUDI ARABIAValid
DERMOVATE OINTMENT 0.05%0.05 %Ointment · Topical1 TubeSAR 9.45Generic · PrescriptionGLAXO SAUDI ARABIAValid
ETRIVEX 0.05% SHAMPOO0.05 %Shampoo · Topical1 BottleSAR 60.55Generic · PrescriptionGALDERMAValid
GAMAVATE 0.05% cream0.05 %Cream · Topical1 TubeSAR 8.95Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
GAMAVATE 0.05% ointment0.05 %Ointment · Topical1 TubeSAR 8.95Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
Glevate0.05 %Cutaneous liquid · Topical1 Spray PumpSAR 60.55Generic · PrescriptionGlenmark Pharmaceuticals LimitedValid
PROMAX 0.05% OINTMENT0.05 %Ointment · Topical1 TubeSAR 8.05Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
CLOBEDERM0.05 %Cream · Topical1 TubeSAR 6.10Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
CLOBEDERM0.05 %Ointment · Topical1 TubeSAR 3.70Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
CLOBEDERM0.05 %Ointment · Topical1 TubeSAR 3.95Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
CORTIMAX CREAM 0.05% W-W0.05 %Cream · Topical1 TubeSAR 6.35Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
CORTIMAX OINTMENT 0.05% W-W0.05 %Ointment · Topical1 TubeSAR 6.80Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
DECLOBAN OINTMENT0.05 %Ointment · Topical1 TubeSAR 7.50Generic · PrescriptionALCON CUSIWithdrawn by MAH · Not Marketed
DELOR 0.05% CREAM0.05 %Cream · Topical1 TubeSAR 5.35Generic · PrescriptionPharma International Co.Withdrawn by MAH · Not Marketed
DELOR 0.05% OINTMENT0.05 %Ointment · Topical1 TubeSAR 5.35Generic · PrescriptionPharma International Co.Withdrawn by MAH · Not Marketed
DERMAL 0.05% CREAM0.05 %Cream · Topical1 TubeSAR 7.05Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
DERMOVATE 0.05% SCALP APPLICATION0.05 %Scalp solution · Topical1 BottleSAR 50.00NCE · PrescriptionGLAXO SAUDI ARABIAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANAL FISSURE; BEHCET DISEASE; ECZEMA; GRAFT VERSUS HOST DISEASE; HUMAN IMMUNODEFICIENCY VIRUS; LICHEN PLANUS; PEMPHIGOID; PEMPHIGUS; PSORIASIS; VITILIGO

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

ProductStrengthForm · routeApplicantStatusFirst approved
CLOBETASOL PROPIONATE0.05%ointment · topicalCOSETTE PHARMS NCPrescription16 Feb 1994
CLOBETASOL PROPIONATE0.05%ointment · topicalFOUGERA PHARMSPrescription23 Feb 1996
CLOBETASOL PROPIONATE0.05%cream · topicalSUN PHARMA CANADAPrescription8 Jul 1996
CLOBETASOL PROPIONATE0.05%ointment · topicalSUN PHARMA CANADAPrescription12 Jul 1996
CLOBETASOL PROPIONATE0.05%cream · topicalFOUGERA PHARMS INCPrescription30 Sep 1996
CLOBETASOL PROPIONATE0.05%gel · topicalPADAGIS USPrescription31 Oct 1997
CLOBETASOL PROPIONATE0.05%ointment · topicalAUROBINDO PHARMA USAPrescription12 Aug 1998
CLOBETASOL PROPIONATE0.05%solution · topicalSUN PHARMA CANADAPrescription16 Nov 1998
CLOBETASOL PROPIONATE0.05%solution · topicalFOUGERA PHARMSPrescription8 Feb 1999
CLOBETASOL PROPIONATE (EMOLLIENT)0.05%cream · topicalFOUGERA PHARMSPrescription26 May 1999
CLOBETASOL PROPIONATE0.05%gel · topicalSUN PHARMA CANADAPrescription28 May 1999
CLOBETASOL PROPIONATE0.05%gel · topicalFOUGERA PHARMSPrescription15 Feb 2000
CLOBETASOL PROPIONATE (EMOLLIENT)0.05%cream · topicalSUN PHARMA CANADAPrescription17 May 2000
CLOBETASOL PROPIONATE0.05%cream · topicalAUROBINDO PHARMA USAPrescription9 Feb 2001
CLOBEX0.05%lotion · topicalGALDERMA LABS LPPrescription24 Jul 2003
CLOBEX0.05%shampoo · topicalGALDERMA LABSPrescription5 Feb 2004
CLOBETASOL PROPIONATE0.05%solution · topicalENCUBEPrescription5 Aug 2005
CLOBEX0.05%spray · topicalGALDERMA LABS LPPrescription27 Oct 2005
CLOBETASOL PROPIONATE0.05%aerosol, foam · topicalPADAGIS ISRAELPrescription10 Mar 2008
CLOBETASOL PROPIONATE0.05%lotion · topicalACTAVIS MID ATLANTICPrescription4 Dec 2008
CLOBETASOL PROPIONATE0.05%lotion · topicalSUN PHARMA CANADAPrescription2 Jul 2012
CLOBETASOL PROPIONATE0.05%shampoo · topicalPADAGIS ISRAELPrescription9 Aug 2012
CLOBETASOL PROPIONATE0.05%aerosol, foam · topicalPADAGIS ISRAELPrescription14 Aug 2012
CLOBETASOL PROPIONATE0.05%solution · topicalNOVEL LABS INCPrescription23 Nov 2015
CLOBETASOL PROPIONATE0.05%spray · topicalZYDUS PHARMSPrescription16 Feb 2017

75 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CLOBEX SHAMPOO022563710.05 %SHAMPOO · TOPICALGALDERMA CANADA INC.
CLOBEX SPRAY022997390.05 % / W/WSPRAY · TOPICALGALDERMA CANADA INC.
DERMOVATE CREAM022132650.05 %CREAM · TOPICALTAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
DERMOVATE OINTMENT022132730.05 %OINTMENT · TOPICALTAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
DERMOVATE SCALP APPLICATION022132810.05 %SOLUTION · TOPICALTAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
JAMP CLOBETASOL SPRAY025346650.05 % / W/WSPRAY · TOPICALJAMP PHARMA CORPORATION
MYLAN-CLOBETASOL CREAM020241870.05 %CREAM · TOPICALMYLAN PHARMACEUTICALS ULC
MYLAN-CLOBETASOL OINTMENT020267670.05 %OINTMENT · TOPICALMYLAN PHARMACEUTICALS ULC
MYLAN-CLOBETASOL SCALP APPLICATION022162130.05 %LOTION · TOPICALMYLAN PHARMACEUTICALS ULC
ODAN CLOBETASOL SPRAY024907060.05 % / W/WSPRAY · TOPICALODAN LABORATORIESLTD
REDDY-CLOBETASOL SHAMPOO025194370.05 %SHAMPOO · TOPICALDR. REDDY'S LABORATORIES CANADA INC.
TARO-CLOBETASOL CREAM USP, 0.05%022455230.05 %CREAM · TOPICALTARO PHARMACEUTICALS INC
TARO-CLOBETASOL OINTMENT USP, 0.05%022455240.05 %OINTMENT · TOPICALTARO PHARMACEUTICALS INC
TARO-CLOBETASOL SHAMPOO025062030.05 % / W/WSHAMPOO · TOPICALTARO PHARMACEUTICALS INC
TARO-CLOBETASOL SPRAY024896190.05 % / W/WSPRAY · TOPICALTARO PHARMACEUTICALS INC
TARO-CLOBETASOL TOPICAL SOLUTION USP, 0.05%022455220.05 %SOLUTION · TOPICALTARO PHARMACEUTICALS INC
TEVA-CLOBETASOL019102720.05 %CREAM · TOPICALTEVA CANADA LIMITED
TEVA-CLOBETASOL019102800.05 %OINTMENT · TOPICALTEVA CANADA LIMITED
TEVA-CLOBETASOL019102990.05 %LOTION · TOPICALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLOBETASOL 0.05% CREAM$0.19302per GM23 Sep 2026
US NADACCLOBETASOL 0.05% CREAM$0.16675per GM23 Sep 2026
US NADACCLOBETASOL 0.05% CREAM$0.12164per GM23 Sep 2026
US NADACCLOBETASOL 0.05% CREAM$0.14036per GM23 Sep 2026
US NADACCLOBETASOL 0.05% GEL$0.86248per GM23 Sep 2026
US NADACCLOBETASOL 0.05% GEL$0.47631per GM23 Sep 2026
US NADACCLOBETASOL 0.05% GEL$0.46115per GM23 Sep 2026
US NADACCLOBETASOL 0.05% OINTMENT$0.13828per GM23 Sep 2026
US NADACCLOBETASOL 0.05% OINTMENT$0.15332per GM23 Sep 2026
US NADACCLOBETASOL 0.05% OINTMENT$0.10833per GM23 Sep 2026
US NADACCLOBETASOL 0.05% OINTMENT$0.11459per GM23 Sep 2026
US NADACCLOBETASOL 0.05% SHAMPOO$0.23313per ML23 Sep 2026
NHS Drug TariffClobetasol 0.05% cream£2.6930 gram1 Oct 2026
NHS Drug TariffClobetasol 0.05% cream£7.90100 gram1 Oct 2026
NHS Drug TariffClobetasol 0.05% ointment£2.6930 gram1 Oct 2026
NHS Drug TariffClobetasol 0.05% ointment£7.90100 gram1 Oct 2026
NHS Drug TariffClobetasol 0.05% scalp application£3.0730 ml1 Oct 2026
NHS Drug TariffClobetasol 0.05% scalp application£10.42100 ml1 Oct 2026
NHS Drug TariffClobetasol 500micrograms/g foam£11.06100 gram1 Oct 2026
NHS Drug TariffClobetasol 500micrograms/g shampoo£9.15125 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.

Safety signals and safety-related labeling changes

  • US FDA 21 Dec 2018 CLOBEX — 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 14 May 2018 OLUX E — 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 25 Apr 2018 OLUX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for clobetasol →

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.