Meloxicam is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) Rheumatoid Arthritis (RA) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg 1.1 Osteoarthritis (OA) Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis. 1.2 Rheumatoid Arthritis (RA) Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2006 | Original application | Approved |
| Nov 21, 2024 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jan 7, 2022 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 22, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 22, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 27, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 4, 2007 | Supplement 1Labeling | Approved | None posted |
| Jul 19, 2006 | Original application | Approved |
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
