Application Nr Approved Date Route Status External Links
ANDA071795 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Sulindac And Other Treatment Options Before Deciding To Use Sulindac. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (See Warnings ). Sulindac Tablets, Usp Are Indicated For Acute Or Long-Term Use In The Relief Of Signs And Symptoms Of The Following: Osteoarthritis Rheumatoid Arthritis** Ankylosing Spondylitis Acute Painful Shoulder (Acute Subacromial Bursitis/supraspinatus Tendinitis) Acute Gouty Arthritis ** The Safety And Effectiveness Of Sulindac Have Not Been Established In Rheumatoid Arthritis Patients Who Are Designated In The American Rheumatism Association Classification As Functional Class Iv (Incapacitated, Largely Or Wholly Bedridden, Or Confined To Wheelchair; Little Or No Self-Care).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sulindac SULINDAC ZINC4475353

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