Application Nr Approved Date Route Status External Links
ANDA202706 2015-10-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Indomethacin Extended-Release Capsules Are Indicated For: Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease Moderate To Severe Ankylosing Spondylitis Moderate To Severe Osteoarthritis Acute Painful Shoulder (bursitis And/or Tendinitis) Indomethacin Extended-Release Capsules Are A Nonsteroidal Anti-Inflammatory Drug Indicated For: Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease Moderate To Severe Ankylosing Spondylitis Moderate To Severe Osteoarthritis Acute Painful Shoulder (bursitis And/or Tendinitis) (1)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Gelatin GELATIN Unresolved
5. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Povidones POVIDONES Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Shellac SHELLAC Unresolved
9. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indomethacin INDOMETHACIN ZINC601283

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