Relieves osteoarthritis. ANDA 77944, held by Lupin Pharms. Meloxicam.
As of Nov 14, 2026, ANDA 77944 (Meloxicam), held by Lupin Pharms, was first approved by FDA on Jul 19, 2006, with 9 approved supplements and 0 published complete response letters.
Meloxicam tablet USP 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 USP are indicated for relief of the signs and symptoms of osteoarthritis. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets USP are indicated for relief of the signs and symptoms of rheumatoid arthritis. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets USP 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 21Labeling · Standard review | Approved | None posted |
| Jan 7, 2022 | Supplement 19Labeling · Standard review | Approved | None posted |
| Oct 4, 2016 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 4, 2016 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jul 1, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jan 28, 2011 | Supplement 9Labeling | Approved | None posted |
| Sep 30, 2010 | Supplement 8Labeling | Approved | None posted |
| Oct 27, 2008 | Supplement 3Labeling | Approved | None posted |
| Mar 29, 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
