Application Nr Approved Date Route Status External Links
NDA021324 2001-10-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Budesonide Is A Glucocorticosteroid 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. (1.2) 1.1 Mild To Moderate Active Crohn’s Disease Budesonide Is Indicated For The Treatment Of Mild To Moderate Active Crohn's Disease Involving The Ileum And/or The Ascending Colon. 1.2 Maintenance Of Clinical Remission Of Mild To Moderate Crohn’s Disease Budesonide Is 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.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
3. Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A Unresolved
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Antifoam M ANTIFOAM M Unresolved
6. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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