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As of Nov 13, 2026, ANDA 75987 (Oxaprozin), held by Chartwell, was first approved by FDA on Sep 2, 2004, with 4 approved supplements and 0 published complete response letters.
First approved: Sep 2, 2004
Supplements approved: 4
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin tablets are non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA) Relief of signs and symptoms of Rheumatoid Arthritis (RA) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA)
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters