Application Nr Approved Date Route Status External Links
ANDA090403 2010-11-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Indomethacin 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) Acute Gouty Arthritis ( 1) Indomethacin 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) Acute Gouty Arthritis

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Powdered Cellulose POWDERED CELLULOSE Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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