Application Nr Approved Date Route Status External Links
ANDA073314 1992-08-31 Rectal RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Carefully Consider The Potential Benefits And Risks Of Indomethacin And Other Treatment Options Before Deciding To Use Indomethacin. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings ). Indomethacin Is Indicated In Active Stages Of The Following: 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 Tendonitis). Acute Gouty Arthritis.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Butylated Hydroxyanisole BUTYLATED HYDROXYANISOLE Molecular
2. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
3. Edetic Acid EDETIC ACID Molecular
4. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Unresolved
6. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved

Active Ingredients ( 1 Total)

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

Comments