Application 021530

Type: NDA
Sponsor: AVONDALE PHARMS

Related Records

Company: AVONDALE PHARMS

Application Products

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001	MOBIC	MELOXICAM	SUSPENSION;ORAL	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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	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	Submission no.	Date	Storage
80387	SUPPL	20	2024-11-25	Cached in FDA.report object storage
80386	SUPPL	20	2024-11-25	Cached in FDA.report object storage
80304	SUPPL	20	2024-11-22	Cached in FDA.report object storage
67329	SUPPL	17	2021-05-03	Cached in FDA.report object storage
67328	SUPPL	17	2021-05-03	Cached in FDA.report object storage
67268	SUPPL	17	2021-04-30	Cached in FDA.report object storage
45226	SUPPL	16	2016-09-01	Cached in FDA.report object storage
45204	SUPPL	16	2016-09-01	Cached in FDA.report object storage
28041	SUPPL	15	2016-05-12	Cached in FDA.report object storage
5658	SUPPL	14	2016-05-12	Cached in FDA.report object storage
37170	SUPPL	15	2016-05-11	Cached in FDA.report object storage
15702	SUPPL	14	2016-05-11	Cached in FDA.report object storage
28040	SUPPL	11	2012-03-12	Cached in FDA.report object storage
15701	SUPPL	11	2012-03-05	Cached in FDA.report object storage
37169	SUPPL	9	2011-08-05	Cached in FDA.report object storage
5657	SUPPL	9	2011-08-05	Cached in FDA.report object storage
28039	SUPPL	8	2010-08-03	Cached in FDA.report object storage
15700	SUPPL	8	2010-08-01	Cached in FDA.report object storage
28038	SUPPL	7	2010-04-29	Cached in FDA.report object storage
37168	SUPPL	7	2010-04-28	Cached in FDA.report object storage
43767	ORIG	1	2009-11-19	FDA source fallback
28037	SUPPL	6	2008-07-01	Cached in FDA.report object storage
15699	SUPPL	6	2008-06-30	Cached in FDA.report object storage
37167	SUPPL	5	2007-02-02	FDA source fallback
5656	SUPPL	5	2007-02-02	FDA source fallback
21719	ORIG	1	2006-03-21	FDA source fallback
37166	SUPPL	1	2005-08-15	FDA source fallback
28036	SUPPL	3	2005-08-15	FDA source fallback
15698	SUPPL	3	2005-08-15	FDA source fallback
5655	SUPPL	1	2005-08-15	FDA source fallback
28035	ORIG	1	2004-06-01	FDA source fallback
15697	ORIG	1	2004-06-01	Cached in FDA.report object storage