Relieves osteoarthritis. ANDA 217579, held by Ascent Pharms Inc. Meloxicam.
As of Nov 14, 2026, ANDA 217579 (Meloxicam), held by Ascent Pharms Inc, was first approved by FDA on Jun 7, 2023, with 1 approved supplement 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 |
|---|---|---|---|
| Jun 7, 2023 | Original application | Approved | None posted |
| Nov 21, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 7, 2023 | Original application | Approved | None posted |
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
