Relieves osteoarthritis. ANDA 77920, held by Aiping Pharm Inc. Meloxicam.
As of Nov 14, 2026, ANDA 77920 (Meloxicam), held by Aiping Pharm Inc, was first approved by FDA on Jul 19, 2006, with 5 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE 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 19, 2006 | Original application | Approved |
| Nov 21, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Dec 28, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 22, 2018 | Supplement 4Manufacturing | Approved | None posted |
| Dec 6, 2016 | Supplement 3Manufacturing | Approved | None posted |
| Oct 25, 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
