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

Indications & Usage Entocort Ec Is Indicated For The Treatment Of Mild To Moderate Active Crohn's Disease Involving The Iluem And/or The Ascending Colon And 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

Comments