budesonide

FDA Drug Profile — budesonide, Uceris, BUDESONIDE, Tarpeyo

Drug Details

Generic Name
budesonide
Brand Names
budesonide, Uceris, BUDESONIDE, Tarpeyo
Application Number
ANDA206134
Sponsor
Major Pharmaceuticals
NDC Codes
15
Dosage Forms
CAPSULE, COATED PELLETS, TABLET, EXTENDED RELEASE, CAPSULE, AEROSOL, FOAM, CAPSULE, DELAYED RELEASE
Routes
ORAL, RECTAL
Active Ingredients
BUDESONIDE

Indications and Usage

1 INDICATIONS AND USAGE Budesonide inhalation suspension is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: • Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.