Relieves osteoarthritis. ANDA 77882, held by Macleods Pharms. Meloxicam.
As of Nov 14, 2026, ANDA 77882 (Meloxicam), held by Macleods Pharms, was first approved by FDA on Jul 20, 2006, with 7 approved supplements and 0 published complete response letters.
. Meloxicam tablets are 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 tablets are indicated for relief of the signs and symptoms of osteoarthritis. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets are 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 20, 2006 | Original application | Approved |
| Nov 21, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 5, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 25, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 25, 2016 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 8, 2009 | Supplement 5Labeling | Approved | None posted |
| Oct 16, 2007 | Supplement 2Labeling | Approved | None posted |
| Jul 20, 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
