Application Nr Approved Date Route Status External Links
ANDA090410 2011-05-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Budesonide Capsules (enteric Coated) Are A Corticosteroid Indicated For: •treatment Of Mild To Moderate Active Crohn’s Disease Involving The Ileum And/or The Ascending Colon. (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. Pediatric Use Information Is Approved For Perrigo Pharma International Dac’s Entocort Ec (budesonide) Capsules. However, Due To Perrigo Pharma International Dac’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. 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 (4 Total)

Name Structure Kind Function Status
1. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Dimethicone DIMETHICONE Molecular
4. Ethylcelluloses ETHYLCELLULOSES Unresolved

Active Ingredients ( 1 Total)

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

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