Application 021530

Type: NDA
Sponsor: AVONDALE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOBIC	MELOXICAM	SUSPENSION;ORAL	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71740-339	Meloxicam	Meloxicam	Avondale Pharmaceuticals, LLC	NDA	Current
72919-124	Meloxicam	MELOXICAM	Emerald Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80387	SUPPL	2024-11-25
80386	SUPPL	2024-11-25
80304	SUPPL	2024-11-22
67329	SUPPL	2021-05-03
67328	SUPPL	2021-05-03
67268	SUPPL	2021-04-30
45226	SUPPL	2016-09-01
45204	SUPPL	2016-09-01
28041	SUPPL	2016-05-12
5658	SUPPL	2016-05-12
37170	SUPPL	2016-05-11
15702	SUPPL	2016-05-11
28040	SUPPL	2012-03-12
15701	SUPPL	2012-03-05
37169	SUPPL	2011-08-05
5657	SUPPL	2011-08-05
28039	SUPPL	2010-08-03
15700	SUPPL	2010-08-01
28038	SUPPL	2010-04-29
37168	SUPPL	2010-04-28
43767	ORIG	2009-11-19
28037	SUPPL	2008-07-01
15699	SUPPL	2008-06-30
37167	SUPPL	2007-02-02
5656	SUPPL	2007-02-02
21719	ORIG	2006-03-21
37166	SUPPL	2005-08-15
28036	SUPPL	2005-08-15
15698	SUPPL	2005-08-15
5655	SUPPL	2005-08-15
28035	ORIG	2004-06-01
15697	ORIG	2004-06-01