Relieves osteoarthritis. ANDA 77918, held by Yung Shin Pharm. Meloxicam.
As of Nov 14, 2026, ANDA 77918 (Meloxicam), held by Yung Shin Pharm, was first approved by FDA on Dec 7, 2006, with 9 approved supplements and 0 published complete response letters.
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 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 |
|---|---|---|---|
| Dec 7, 2006 | Original application | Approved | None posted |
| Dec 23, 2024 | Supplement 10Manufacturing | Approved | None posted |
| Nov 21, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 29, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 22, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 22, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 12, 2013 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 10, 2010 | Supplement 3Labeling | Approved | None posted |
| Sep 24, 2009 | Supplement 2Labeling | Approved | None posted |
| May 27, 2009 | Supplement 1Labeling | Approved | None posted |
| Dec 7, 2006 | 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
