formoterol fumarate
formoterol fumarate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including formoterol fumarate, Formoterol Fumarate. Available dosage forms: powder, solution.
Drug Details
- Generic Name
- formoterol fumarate
- Brand Names
- formoterol fumarate, Formoterol Fumarate
- Application Number
- ANDA215053
- Sponsor
- Fermion Oy
- NDC Codes
- 3
- Dosage Forms
- POWDER, SOLUTION
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FORMOTEROL FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1.1 ) • the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. ( 1.3 , 5.1 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREZTRI AEROSPHERE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. 1.2 Maintenance Treatment of Asthma BREZTRI AEROSPHERE is indicated for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. 1.3 Limitations of Use BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm [see Warnings and Precautions (5.1 , 5.2) ] .