budesonide

FDA Drug Profile — budesonide, Uceris, Tarpeyo, BUDESONIDE

Drug Details

Generic Name
budesonide
Brand Names
budesonide, Uceris, Tarpeyo, BUDESONIDE
Application Number
NDA021324
Sponsor
Cosmo SpA
NDC Codes
16
Dosage Forms
TABLET, EXTENDED RELEASE, CAPSULE, CAPSULE, COATED PELLETS, CAPSULE, DELAYED RELEASE, AEROSOL, FOAM
Routes
ORAL, RECTAL
Active Ingredients
BUDESONIDE

Indications and Usage

1 INDICATIONS AND USAGE PULMICORT FLEXHALER is a corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Treatment of Asthma PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Limitations of Use: •PULMICORT FLEXHALER is NOT indicated for the relief of acute bronchospasm.