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001	MOBIC	MELOXICAM	SUSPENSION;ORAL	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021530-001	MELOXICAM	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, RS	2004-06-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021530-001	6184220	2019-03-25	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021530-001	6184220	2019-03-25	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021530-001	6184220	2019-03-25	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021530-001	6184220	2019-03-25	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meloxicam	MELOXICAM	Emerald Therapeutics, LLC	55af77dd-2abc-49a6-990c-399d5a5e7a91	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021530 application number: NDA021530 ndc (product): 72919-124

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

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