Application 076009

Type: ANDA
Sponsor: CHARTWELL MOLECULES

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	No

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
A076009-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2003-01-24
A076009-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2003-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076009-001	AB
A076009-002	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076009-001	NABUMETONE	500MG	TABLET / ORAL	AB	2003-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076009-002	NABUMETONE	750MG	TABLET / ORAL	AB	2003-01-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076009-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076009-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076009-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076009-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076009-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076009-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076009-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076009-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076009-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076009-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076009-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076009-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076009-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076009-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076009-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076009-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076009-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076009-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076009-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076009-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076009-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076009-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076009-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076009-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076009-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076009-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076009-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076009-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076009-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076009-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076009-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076009-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076009-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076009-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076009-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076009-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076009-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076009-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076009-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076009-002	AB	1	`74a2ff9319b5…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-273	Nabumetone	Nabumetone	Blenheim Pharmacal, Inc.	ANDA	Current
49884-649	Nabumetone	Nabumetone	Par Pharmaceutical Inc	ANDA	Current
49884-650	Nabumetone	Nabumetone	Par Pharmaceutical Inc	ANDA	Current
63874-607	Nabumetone	Nabumetone	Altura Pharmaceuticals, Inc.	ANDA	Current
63874-687	Nabumetone	Nabumetone	Altura Pharmaceuticals, Inc.	ANDA	Current