Meloxicam

ANDA 77928, held by Novitium Pharma. Meloxicam.

As of Nov 14, 2026, ANDA 77928 (Meloxicam), held by Novitium Pharma, was first approved by FDA on May 13, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: May 13, 2009
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 13, 2009	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Oct 23, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 4Labeling · Standard review	Approved	None posted
May 13, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 77928
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