Application Nr Approved Date Route Status External Links
NDA018851 1984-05-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Indomethacin Capsules Are Indicated For: 1. Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease 2. Moderate To Severe Ankylosing Spondylitis 3. Moderate To Severe Osteoarthritis 4. Acute Painful Shoulder (bursitis And/or Tendinitis) 5. Acute Gouty Arthritis Indomethacin Capsules, Usp Are Non Steroidal Anti-Inflammatory Drug Indicated For ( 1 ) 1. Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease 2. Moderate To Severe Ankylosing Spondylitis. 3. Moderate To Severe Osteoarthritis 4. Acute Painful Shoulder (bursitis And/or Tendinitis). 5. Acute Gouty Arthritis

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Povidones POVIDONES Unresolved
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
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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