Meloxicam

ANDA 77937, held by Sun Pharm Inds Inc. Meloxicam.

As of Nov 14, 2026, ANDA 77937 (Meloxicam), held by Sun Pharm Inds Inc, was first approved by FDA on Jul 19, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2006
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 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 5 submissions, including labeling and manufacturing supplements


Dec 31, 2008	Supplement 9Labeling	Approved	None posted
Feb 29, 2008	Supplement 4Labeling	Approved	None posted
Aug 9, 2007	Supplement 3Labeling	Approved	None posted
Jun 19, 2007	Supplement 1Labeling	Approved	None posted
Jul 19, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77937
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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