Application 075189

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NABUMETONE	NABUMETONE	TABLET;ORAL	500MG	No	No
002	NABUMETONE	NABUMETONE	TABLET;ORAL	750MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075189-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL			2000-05-26
A075189-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL			2001-09-24

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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075189-001	NABUMETONE	500MG	TABLET / ORAL	AB		2000-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075189-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2001-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075189-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075189-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075189-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075189-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075189-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075189-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075189-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075189-002	AB	1	`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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Preferred Pharmaceuticals, Inc.	95769e02-fa4a-4389-a2fa-3146eae02526	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Preferred Pharmaceuticals Inc.	455c9992-39a0-4353-a121-57e700c77942	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	ANI Pharmaceuticals, Inc.	e87289f4-d4f9-4510-aaa5-51f8f8167658	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	St. Mary's Medical Park Pharmacy	95aa8124-08fe-ff2f-e053-2a95a90a3c8f	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	REMEDYREPACK INC.	311ae656-55d2-4116-a1bd-6f4a4ce70185	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	St. Mary's Medical Park Pharmacy	94930125-b792-579e-e053-2995a90ab6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	REMEDYREPACK INC.	6106afa3-e138-4b4d-8c13-992bf5062097	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Northwind Health Company, LLC	b088f564-43ff-8007-e053-2995a90ab012	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Northwind Health Company, LLC	d9ca2484-7293-7db6-e053-2995a90a0f13	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Northwind Health Company, LLC	da34003b-81a4-2efd-e053-2995a90a961c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Redpharm Drug	3745775e-e11a-01db-e063-6294a90a9b52	2025-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	75c51686-9c5e-4c13-acf4-2d04502eedda	2025-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	American Health Packaging	0653b873-b74b-4ec6-b112-675760703d91	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	0186328f-3eb7-4407-bf9e-8007d08ebe7b	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	dd0d2652-d335-45db-af43-5a2523f7299a	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone 500 mg	NABUMETONE	LGM PHARMA SOLUTIONS, LLC	ef7c3da8-797f-4ea9-8999-53509785a0f7	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NABUMETONE
Nabumetone	NABUMETONE	Actavis Pharma, Inc.	53656d70-6572-4669-6465-6c6973555341	2025-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	8f3c1b1d-2765-4cb5-92df-044b99339c92	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	583602ff-dbbe-4369-afa9-b917734ac9b1	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	b2a41c0b-e2ad-4e14-a2f7-2049c12c35da	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1657	Nabumetone	Nabumetone	Impax Generics	ANDA	Current
0115-1657	Nabumetone	Nabumetone	Impax Generics	ANDA	Current
0115-1657	Nabumetone	Nabumetone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1658	Nabumetone	Nabumetone	Impax Generics	ANDA	Current
0115-1658	Nabumetone	Nabumetone	Impax Generics	ANDA	Current
0115-1658	Nabumetone	Nabumetone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0615-7666	Nabumetone	Nabumetone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7667	Nabumetone	Nabumetone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43063-859	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-859	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-859	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-859	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-859	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-997	Nabumetone	Nabumetone	medsource pharmaceuticals	ANDA	Current
55700-752	Nabumetone	Nabumetone	Quality Care Products, LLC	ANDA	Current
55700-765	Nabumetone	Nabumetone	Quality Care Products, LLC	ANDA	Current
55700-765	Nabumetone	Nabumetone	Quality Care Products, LLC	ANDA	Current
61919-159	NABUMETONE	NABUMETONE	Direct Rx	ANDA	Current
61919-159	NABUMETONE	NABUMETONE	DIRECT RX	ANDA	Current
61919-159	NABUMETONE	NABUMETONE	DIRECT RX	ANDA	Current
61919-160	NABUMETONE	NABUMETONE	Direct Rx	ANDA	Current
68788-7532	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7532	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8557	ORIG	2004-06-09
30789	SUPPL	2003-04-09
30788	SUPPL	2003-04-09
42956	ORIG	2000-05-26
30787	ORIG	2000-05-26
18392	ORIG	2000-05-26