Meloxicam

ANDA 77936, held by Chartwell Rx. Meloxicam.

As of Nov 14, 2026, ANDA 77936 (Meloxicam), held by Chartwell Rx, was first approved by FDA on Jul 19, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2006
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 19, 2006	Original application	Approved	Letter

Products

2 strengths and forms


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

All 14 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Nov 19, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Jun 13, 2013	Supplement 14Labeling · Standard review	Approved	None posted
Dec 2, 2010	Supplement 11Labeling	Approved	None posted
Jul 7, 2010	Supplement 10Labeling	Approved	None posted
Oct 9, 2008	Supplement 7Labeling	Approved	None posted
Jun 28, 2008	Supplement 6Labeling	Approved	None posted
Feb 11, 2008	Supplement 4Labeling	Approved	None posted
Jun 19, 2007	Supplement 3Labeling	Approved	None posted
Jun 7, 2007	Supplement 2Labeling	Approved	None posted
Jul 19, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77936
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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