Budesonide

Product manufactured by Appco Pharma Llc

Application Nr Approved Date Route Status External Links
ANDA207367 2017-04-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Budesonide Capsules Is 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 Is 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 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 In Adults.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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