Meloxicam

Relieves osteoarthritis. NDA 21530, held by Avondale Pharms. Meloxicam.

As of Nov 14, 2026, NDA 21530 (Meloxicam), held by Avondale Pharms, was first approved by FDA on Jun 1, 2004, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2004
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Meloxicam oral suspension is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) Rheumatoid Arthritis (RA) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older 1.1 Osteoarthritis (OA) Meloxicam oral suspension is indicated for relief of the signs and symptoms of osteoarthritis. 1.2 Rheumatoid Arthritis (RA) Meloxicam oral suspension is indicated for relief of the signs and symptoms of rheumatoid arthritis. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Aug 11, 2005	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 1, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meloxicam7.5MG/5ML · suspension;oral	Meloxicam	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 20Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 1, 2016	Supplement 16Labeling · Standard review	Approved	Label Letter
May 9, 2016	Supplement 15Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 12, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 5, 2012	Supplement 11Labeling	Approved	Letter Label
Aug 3, 2011	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 29, 2010	Supplement 8Labeling · Standard review	Approved	Letter Label
Apr 26, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Jun 27, 2008	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 25, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 11, 2005	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 11, 2005	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 1, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21530
Drugs@FDA: Overview at FDA
Company: Avondale Pharmaceuticals

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