formoterol fumarate dihydrate
formoterol fumarate dihydrate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Formoterol Fumarate Inhalation Solution, FORMOTEROL FUMARATE, Perforomist. Available dosage form: solution.
Drug Details
- Generic Name
- formoterol fumarate dihydrate
- Brand Names
- Formoterol Fumarate Inhalation Solution, FORMOTEROL FUMARATE, Perforomist
- Application Number
- ANDA216486
- Sponsor
- Ritedose Pharmaceuticals, LLC
- NDC Codes
- 3
- Dosage Forms
- SOLUTION
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FORMOTEROL FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE PERFOROMIST Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1 ) Important limitations of use: • PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) • PERFOROMIST Inhalation Solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD PERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 1.2 Important Limitations of Use PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2) ]. PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.