Application Nr Approved Date Route Status External Links
ANDA205710 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Budesonide BUDESONIDE ZINC3938751

Comments