Application Nr Approved Date Route Status External Links
ANDA206134 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Budesonide Capsules (Enteric Coated) Are Corticosteroid Indicated For: Treatment Of Mild To Moderate Active Crohn's Disease Involving The Ileum And/or The Ascending Colon, In Patients 8 Years And Older. ( 1.1 ) Maintenance Of Clinical Remission Of Mild To Moderate Crohn's Disease Involving The Ileum And/or The Ascending Colon For Up To 3 Months In Adults. ( 1.2 ) 1.1 Treatment Of Mild To Moderate Active Crohn’s Disease Budesonide Capsules (Enteric Coated) Are Indicated For The Treatment Of Mild To Moderate Active Crohn's Disease Involving The Ileum And/or The Ascending Colon In Patients 8 Years Of Age And Older. 1.2 Maintenance Of Clinical Remission Of Mild To Moderate Crohn’s Disease Budesonide Capsules (Enteric Coated) Are Indicated For The Maintenance Of Clinical Remission Of Mild To Moderate Crohn's Disease Involving The Ileum And/or The Ascending Colon For Up To 3 Months In Adults.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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