Application 203166

Type: ANDA
Sponsor: NEXGEN PHARMA 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
003	NABUMETONE	NABUMETONE	TABLET;ORAL	1GM	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203166-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30
A203166-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30
A203166-003	NABUMETONE	NABUMETONE	1GM	TABLET / ORAL		RS	2019-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203166-001	AB
A203166-002	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 4 · 123 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	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203166-003	NABUMETONE	1GM	TABLET / ORAL		RS	2019-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203166-003	NABUMETONE	1GM	TABLET / ORAL		RS	2019-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	A203166-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203166-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203166-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203166-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203166-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203166-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203166-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203166-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203166-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203166-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203166-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203166-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203166-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203166-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203166-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203166-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203166-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203166-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203166-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203166-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203166-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203166-002	AB	1	`bb7c543d1eb4…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone 500 mg	NABUMETONE	LGM PHARMA SOLUTIONS, LLC	ef7c3da8-797f-4ea9-8999-53509785a0f7	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203166 application number: ANDA203166 ndc (product): 79739-7077 ndc (product): 79739-7076 ndc (product): 79739-7078
RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	2024-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203166 application number: ANDA203166 ndc (product): 15370-170

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0722-7076	Nabumetone 500 mg	Nabumetone	Nexgen Pharma, Inc.	ANDA	Current
0722-7077	Nabumetone 750 mg	Nabumetone	Nexgen Pharma, Inc.	ANDA	Current
0722-7078	Nabumetone 1000 mg	Nabumetone	Nexgen Pharma, Inc.	ANDA	Current
15370-170	RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	ANDA	Current
15370-170	RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	ANDA	Current
15370-170	RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	ANDA	Current
15370-170	RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	ANDA	Current
73684-100	RELAFEN	NABUMETONE	BLUCREST PHARMACEUTICALS LLC	ANDA	Current
73684-100	RELAFEN	NABUMETONE	BLUCREST PHARMACEUTICALS LLC	ANDA	Current
73684-101	RELAFEN	NABUMETONE	BLUCREST PHARMACEUTICALS LLC	ANDA	Current
73684-101	RELAFEN	NABUMETONE	BLUCREST PHARMACEUTICALS LLC	ANDA	Current
79739-7076	Nabumetone 500 mg	Nabumetone	LGM Pharma Solutions, LLC	ANDA	Current
79739-7076	Nabumetone 500 mg	Nabumetone	LGM Pharma Solutions, LLC	ANDA	Current
79739-7077	Nabumetone 750 mg	Nabumetone	LGM Pharma Solutions, LLC	ANDA	Current
79739-7077	Nabumetone 750 mg	Nabumetone	LGM Pharma Solutions, LLC	ANDA	Current
79739-7078	Nabumetone 1000 mg	Nabumetone	LGM Pharma Solutions, LLC	ANDA	Current
79739-7078	Nabumetone 1000 mg	Nabumetone	LGM Pharma Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60146	ORIG	2019-09-27