Application 078420

Type: ANDA
Sponsor: SCIEGEN PHARMS 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	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
A078420-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-09-24
A078420-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2008-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078420-001	AB
A078420-002	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	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078420-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078420-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078420-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078420-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078420-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078420-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078420-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078420-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078420-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078420-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078420-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078420-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078420-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078420-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078420-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078420-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078420-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078420-002	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 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Sportpharm LLC	55e733f0-7633-4412-b5a3-07d9363bbd71	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Preferred Pharmaceuticals, Inc.	95769e02-fa4a-4389-a2fa-3146eae02526	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Preferred Pharmaceuticals Inc.	455c9992-39a0-4353-a121-57e700c77942	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	St. Mary's Medical Park Pharmacy	95aa8124-08fe-ff2f-e053-2a95a90a3c8f	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	REMEDYREPACK INC.	311ae656-55d2-4116-a1bd-6f4a4ce70185	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	St. Mary's Medical Park Pharmacy	94930125-b792-579e-e053-2995a90ab6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	REMEDYREPACK INC.	6106afa3-e138-4b4d-8c13-992bf5062097	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Northwind Health Company, LLC	d9ca2484-7293-7db6-e053-2995a90a0f13	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Northwind Health Company, LLC	da34003b-81a4-2efd-e053-2995a90a961c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Redpharm Drug	3745775e-e11a-01db-e063-6294a90a9b52	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	75c51686-9c5e-4c13-acf4-2d04502eedda	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	583602ff-dbbe-4369-afa9-b917734ac9b1	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	b2a41c0b-e2ad-4e14-a2f7-2049c12c35da	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	ad9f2a34-6244-49b7-98ee-af18cb55693c	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	06f73fa8-7a8f-4160-939e-a25980a11906	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	5a66c21f-4f06-4fb8-98fa-e81949586afd	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	419c597f-6a6f-4420-b240-7dc4c223387e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	a4553637-498e-491a-982a-cff81b43aa6c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	5ba602e9-846e-42b3-9ea6-fb461a948947	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	0be7ee60-2706-43ed-98ec-b89cd4e2b57c	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420

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 2 of 2 · 95 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-210	Nabumetone	Nabumetone	Asclemed USA, Inc.	ANDA	Current
80425-0054	Relafen	Nabumetone 500mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0054	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0054	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0054	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0104	Relafen	Nabumetone 750mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0104	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0104	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current