Meloxicam

Relieves osteoarthritis. ANDA 77921, held by Zydus Pharms USA. Meloxicam.

As of Nov 14, 2026, ANDA 77921 (Meloxicam), held by Zydus Pharms USA, was first approved by FDA on Jul 19, 2006, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2006
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Meloxicam Tablets are 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 19, 2006	Original application	Approved	Letter

Products

2 strengths and forms


Meloxicam7.5MG · tablet;oral	Meloxicam	Rx
Meloxicam15MG · tablet;oral	Meloxicam	Rx

All 15 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 38Labeling · Standard review	Approved	None posted
Jan 5, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Aug 15, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Aug 15, 2016	Supplement 29Labeling · Standard review	Approved	None posted
Apr 20, 2016	Supplement 14Manufacturing	Approved	None posted
Sep 10, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Sep 10, 2015	Supplement 18Labeling	Approved	None posted
Sep 10, 2015	Supplement 17Labeling	Approved	None posted
Sep 3, 2014	Supplement 9Labeling	Approved	None posted
Oct 26, 2010	Supplement 15Labeling	Approved	None posted
Oct 26, 2010	Supplement 13Labeling	Approved	None posted
Aug 27, 2010	Supplement 12Labeling	Approved	None posted
Sep 23, 2008	Supplement 7Labeling	Approved	None posted
Nov 20, 2007	Supplement 2Labeling	Approved	None posted
Jul 19, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77921
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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