Mobic

NDA 20938, held by Boehringer Ingelheim. Meloxicam.

As of Nov 14, 2026, NDA 20938 (Mobic), held by Boehringer Ingelheim, was first approved by FDA on Apr 13, 2000, with 22 approved supplements and 0 published complete response letters.

First approved: Apr 13, 2000
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Aug 11, 2005	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Jul 16, 2004	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 13, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Mobic7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Meloxicam	DiscontinuedReference drug
Mobic15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Meloxicam	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 30Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 28Labeling · Standard review	Approved	Label Letter
Jun 30, 2016	Supplement 26Labeling · Standard review	Approved	Label Letter
May 9, 2016	Supplement 24Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 25Labeling · Standard review	Approved	Letter Label
Mar 5, 2012	Supplement 22Labeling	Approved	Letter Label
Aug 3, 2011	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 29, 2010	Supplement 20Labeling	Approved	Letter Label
Apr 26, 2010	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 27, 2008	Supplement 18Labeling · Standard review	Approved	Letter Label
Jan 25, 2007	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 11, 2005	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Aug 11, 2005	Supplement 15Labeling · Standard review	Approved	Label Letter
Jul 16, 2004	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 28, 2003	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 13, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 21, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 10, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 10, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 15, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 14, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 23, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 13, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20938
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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