Application Nr Approved Date Route Status External Links
NDA021324 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Budesonide Extended-Release Capsules Are A 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 Extended-Release Capsules 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 Extended-Release Capsules 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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