Meloxicam

ANDA 77923, held by Natco Pharma. Meloxicam.

As of Nov 14, 2026, ANDA 77923 (Meloxicam), held by Natco Pharma, was first approved by FDA on Jul 19, 2006, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2006
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 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 9 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Jan 5, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Sep 8, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Sep 8, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Sep 8, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Jun 12, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Sep 4, 2009	Supplement 4Labeling	Approved	None posted
Feb 21, 2008	Supplement 2Labeling	Approved	None posted
Jul 19, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77923
Drugs@FDA: Overview at FDA
Company: Natco 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