Application Nr Approved Date Route Status External Links
ANDA204853 2017-05-08 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 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) 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)

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Povidones POVIDONES Unresolved
3. 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.
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
6. Ammonio Methacrylate Copolymer AMMONIO METHACRYLATE COPOLYMER Unresolved
7. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Gelatin GELATIN Unresolved
9. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
10. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

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

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