Regulatory PathRegulatory requirements compared

Active substance

Alclometasone

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ALCLOMETASONE DIPROPIONATE0.05%ointment · topicalSUN PHARMA CANADAPrescription29 Jul 2004
ALCLOMETASONE DIPROPIONATE0.05%cream · topicalFOUGERA PHARMSPrescription12 Jul 2005
ALCLOMETASONE DIPROPIONATE0.05%ointment · topicalFOUGERA PHARMSPrescription18 Jul 2005
ALCLOMETASONE DIPROPIONATE0.05%cream · topicalSUN PHARMA CANADAPrescription15 Sep 2005
ACLOVATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ointment · topicalFOUGERADiscontinued14 Dec 1982
ACLOVATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**cream · topicalFOUGERADiscontinued14 Dec 1982
ALCLOMETASONE DIPROPIONATE0.05%cream · topicalGLENMARK PHARMS LTDDiscontinued23 Jun 2009
ALCLOMETASONE DIPROPIONATE0.05%ointment · topicalGLENMARK PHARMS LTDDiscontinued30 Jul 2009

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
ALCLOMETASONE DIPROPIONATE 0.05% W/W CREAMPL 35533/0078ASPIRE PHARMA LIMITEDPOM
MODRASONE OINTMENTPL 35533/0096ASPIRE PHARMA LIMITEDPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.