Active substances
Formoterol + Mometasone
- US FDA 1
- EMA 1
- Health Canada 2
- US price lines 5
- WHO EML 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DULERA | 0.005MG/INH;0.1MG/INH; 0.005MG/INH;0.2MG/INH; 0.005MG/INH;0.05MG/INH | aerosol, metered · inhalation | ORGANON LLC | Prescription | 22 Jun 2010 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DULERA 100 MCG-5 MCG INHALER | $25.19157 | per GM | 23 Sep 2026 |
| US NADAC | DULERA 100 MCG-5 MCG INHALER | $25.24577 | per GM | 23 Sep 2026 |
| US NADAC | DULERA 200 MCG-5 MCG INHALER | $25.18275 | per GM | 23 Sep 2026 |
| US NADAC | DULERA 200 MCG-5 MCG INHALER | $25.26136 | per GM | 23 Sep 2026 |
| US NADAC | DULERA 50 MCG-5 MCG INHALER | $25.19279 | per GM | 23 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.
WHO WHO Model List of Essential Medicines (2025)
- 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Therapeutic equivalent to budesonide + formoterol for Asthma
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.