Meloxicam

Manages osteoarthritis pain. ANDA 211398, held by Novitium Pharma. Meloxicam.

As of Nov 14, 2026, ANDA 211398 (Meloxicam), held by Novitium Pharma, was first approved by FDA on Mar 9, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 9, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Meloxicam is indicated for management of osteoarthritis pain. Meloxicam is a non-steroidal anti-inflammatory drug indicated for management of osteoarthritis (OA) pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 9, 2021	Original application	Approved	None posted

Products

2 strengths and forms


Meloxicam5MG · capsule;oral	Meloxicam	Rx
Meloxicam10MG · capsule;oral	Meloxicam	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Oct 11, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Mar 9, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 211398
Drugs@FDA: Overview at FDA
Company: Novitium 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