Meloxicam

Relieves osteoarthritis. ANDA 78008, held by Aurobindo Pharma. Meloxicam.

As of Nov 14, 2026, ANDA 78008 (Meloxicam), held by Aurobindo Pharma, was first approved by FDA on Oct 2, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 2, 2006
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 2, 2006	Original application	Approved	None posted

Products

2 strengths and forms


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

All 14 submissions, including labeling and manufacturing supplements


Sep 16, 2026	Supplement 28Labeling · Standard review	Approved	None posted
Nov 21, 2024	Supplement 26Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Dec 2, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Dec 2, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Jun 10, 2013	Supplement 10Labeling	Approved	None posted
Jun 10, 2013	Supplement 13Labeling · Standard review	Approved	None posted
Oct 31, 2011	Supplement 9Labeling	Approved	None posted
Jan 28, 2011	Supplement 6Labeling	Approved	None posted
Nov 18, 2009	Supplement 5Labeling	Approved	None posted
Aug 22, 2008	Supplement 3Labeling	Approved	None posted
May 8, 2008	Supplement 2Labeling	Approved	None posted
Mar 28, 2007	Supplement 1Labeling	Approved	None posted
Oct 2, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 78008
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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