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 2 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Nabumetone	NABUMETONE	Bryant Ranch Prepack	ad9f2a34-6244-49b7-98ee-af18cb55693c	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	06f73fa8-7a8f-4160-939e-a25980a11906	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	5a66c21f-4f06-4fb8-98fa-e81949586afd	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	419c597f-6a6f-4420-b240-7dc4c223387e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	a4553637-498e-491a-982a-cff81b43aa6c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	5ba602e9-846e-42b3-9ea6-fb461a948947	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Bryant Ranch Prepack	0be7ee60-2706-43ed-98ec-b89cd4e2b57c	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Exelan Pharmaceuticals Inc.	16e76e29-9315-40c0-b1d6-8d91961063cf	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Cipla USA Inc.	85954380-a520-46d7-89ac-e4b19d6e00a1	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	69620c53-b37a-45b9-b560-221bbcd98fda	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
NABUMETONE	NABUMETONE	direct rx	a8600b12-f180-0b27-e053-2995a90acbd9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NABUMETONE generic name: NABUMETONE
Nabumetone	NABUMETONE	ScieGen Pharmaceuticals Inc	80c6888d-03b4-44f3-b94d-bcf5154ceae5	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9969df-ce14-c0bc-e053-2995a90a3f59	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9994ac-6687-2df2-e053-2995a90a959a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Advanced Rx Pharmacy of Tennessee, LLC	b43db4aa-6013-3942-e053-2a95a90a5189	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Quality Care Products, LLC	da259c7c-6f1e-403c-b42b-596d53b61fe5	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	Quality Care Products, LLC	065fdacc-739e-4b46-bebc-044b5c11bbbb	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	A-S Medication Solutions	26037234-daca-4f1a-a7a7-0871f77283f0	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nabumetone generic name: NABUMETONE
Nabumetone	NABUMETONE	A-S Medication Solutions	d997d125-dfc5-4cc5-b7a6-03f5a7248d14	2024-10-25	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