Regulatory PathRegulatory requirements compared

Active substances

Adapalene + Benzoyl peroxide + Clindamycin

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CABTREO0.15%;3.1%;1.2%gel · topicalBAUSCHPrescription20 Oct 2023

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CABTREO025504230.15 % / W/W; 3.1 % / W/W; 1.2 % / W/WGEL · TOPICALBAUSCH HEALTH, CANADA INC.

Components

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.