Meloxicam

ANDA 77932, held by Glenmark Pharms Ltd. Meloxicam.

As of Nov 14, 2026, ANDA 77932 (Meloxicam), held by Glenmark Pharms Ltd, was first approved by FDA on Jul 19, 2006, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2006
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 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 10 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Sep 25, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Sep 25, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Sep 25, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jun 10, 2013	Supplement 5Labeling	Approved	None posted
Jun 10, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Jun 15, 2010	Supplement 2Labeling	Approved	None posted
Aug 14, 2007	Supplement 1Labeling	Approved	None posted
Jul 19, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77932
Drugs@FDA: Overview at FDA
Company: Glenmark 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