Meloxicam

ANDA 78039, held by Cr Double Crane. Meloxicam.

As of Nov 14, 2026, ANDA 78039 (Meloxicam), held by Cr Double Crane, was first approved by FDA on Dec 14, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2006
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 14, 2006	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 26, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Nov 28, 2014	Supplement 2Manufacturing	Approved	None posted
Dec 14, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 78039
Drugs@FDA: Overview at FDA
Company: CR Double-Crane

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