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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`84e616aacf4f…`
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…`

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 3 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Westminster Pharmaceuticals, LLC	264df44a-e294-4d9b-9113-92859cb08c20	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	62f2e0bf-e5c8-480c-ac5e-401ced3bbc67	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	2024-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NABUMETONE
Nabumetone	NABUMETONE	Lupin Pharmaceuticals, Inc.	cf96d189-5417-4181-a5fb-169b269560a2	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Chartwell RX, LLC	84bb2887-bab4-46ae-a07c-fa2a32c04b50	2023-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Proficient Rx LP	0870c3c9-bfce-4722-8779-8775644196d3	2022-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Proficient Rx LP	7a1643bf-6627-4b12-8246-6acc40517cf2	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Proficient Rx LP	f4392863-ed3f-4fbd-8260-49827609aa2e	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Asclemed USA, Inc.	04a71deb-2c9d-436c-a574-e5991b6a5248	2022-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Proficient Rx LP	079a8a9e-6d71-414a-83f3-ef68e323c1fd	2020-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE

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 · 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