mometasone furoate and formoterol fumarate dihydrate
Drug Details
- Generic Name
- mometasone furoate and formoterol fumarate dihydrate
- Brand Names
- Dulera
- Application Number
- NDA022518
- Sponsor
- Organon LLC
- NDC Codes
- 3
- Dosage Forms
- AEROSOL
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FORMOTEROL FUMARATE, MOMETASONE FUROATE
Indications and Usage
1 INDICATIONS AND USAGE DULERA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. ( 1.1 ) Important Limitation of Use: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. DULERA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use: DULERA is NOT indicated for the relief of acute bronchospasm.