Regulatory PathRegulatory requirements compared

Active substance

Prednicarbate

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PREDNICARBATE0.1%ointment · topicalFOUGERA PHARMSPrescription9 Mar 2007
DERMATOP0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ointment · topicalVALEANT PHARMS NORTHDiscontinued23 Sep 1991
DERMATOP E EMOLLIENT0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**cream · topicalVALEANT BERMUDADiscontinued29 Oct 1993
PREDNICARBATE0.1%cream · topicalFOUGERA PHARMSDiscontinued19 Sep 2006

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DERMATOP EMOLLIENT CREAM022306420.1 % / W/WCREAM · TOPICALBAUSCH HEALTH, CANADA INC.

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.