Application 017581

Type: NDA
Sponsor: ATNAHS PHARMA US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NAPROSYN	NAPROXEN	TABLET;ORAL	250MG	Yes	No
003	NAPROSYN	NAPROXEN	TABLET;ORAL	375MG	Yes	No
004	NAPROSYN	NAPROXEN	TABLET;ORAL	500MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N017581-002	NAPROSYN	NAPROXEN	250MG	TABLET / ORAL		RLD, Approved before 1982
N017581-003	NAPROSYN	NAPROXEN	375MG	TABLET / ORAL		RLD, Approved before 1982
N017581-004	NAPROSYN	NAPROXEN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017581-004	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 · 129 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	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	N017581-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017581-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017581-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017581-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017581-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017581-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017581-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017581-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017581-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017581-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017581-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017581-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017581-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017581-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017581-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017581-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017581-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017581-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017581-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017581-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017581-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017581-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017581-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017581-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017581-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017581-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017581-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017581-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017581-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017581-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017581-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017581-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017581-004	AB	1	`f41ea6bd6efb…`

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 6 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Medsource Pharmaceuticals	12648efc-3be8-a915-e063-6394a90a3620	2024-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	1cdcaba5-5550-40f6-94cc-b0a98cc17d3c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	d564f52d-171c-4e7d-974c-3a0e192e6c12	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	f91c1a6b-b256-42e1-9da0-5f1975dec6ce	2023-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	a8b54258-84e7-41e8-9e51-137a3f442e6b	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	50c52976-9e04-4a5e-9f21-aca3ea5c2924	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	d801ba16-e2ec-4bb2-8cff-32388634b35a	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	21930f73-d3c2-4462-a487-74ed871b74b2	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	a5ea3a84-7acd-4f24-9f0f-9f871ce1b5f4	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
naproxen	NAPROXEN	Cipla USA Inc.	a9549a47-3fa4-4a2b-95ac-b00e43aedae7	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	d0670241-f1f9-4fdf-83d4-547e7b800811	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
NAPROXEN	NAPROXEN	Asclemed USA, Inc.	a4fcb411-c918-459b-adc6-06dfa8ed8a50	2022-10-12	Warnings	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	aa4d159c-9cbe-4d29-9532-33a312f1ae05	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	96601d76-50ea-4dc0-b588-d174f8d8bb51	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	98efdeb8-ea38-456e-953f-ba589727f284	2021-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	9c963e77-6e05-47d0-a8d3-e581777377b9	2021-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
NAPROXEN	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	32693390-763b-46dd-b821-65a7bf3c6671	2021-04-26	Warnings	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	fc3ee94a-adb7-411e-a662-2f2c6ddbabaf	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	3e4e5371-d796-47c7-95c1-d99e82a0b282	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42494-403	NAPROXEN	naproxen	Cameron Pharmaceuticals, LLC	NDA	Current
42494-404	NAPROXEN	naproxen	Cameron Pharmaceuticals, LLC	NDA	Current
42494-405	NAPROXEN	naproxen	Cameron Pharmaceuticals, LLC	NDA	Current
69437-316	Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-316	Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-316	Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-316	Naprosyn	naproxen	Canton Laboratories	NDA	Current
69784-505	NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-505	NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-505	NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80351	SUPPL	2024-11-25
80291	SUPPL	2024-11-22
80290	SUPPL	2024-11-22
78456	SUPPL	2024-05-14
78455	SUPPL	2024-05-14
67236	SUPPL	2021-04-29
67233	SUPPL	2021-04-29
67232	SUPPL	2021-04-29
59427	SUPPL	2019-07-23
59426	SUPPL	2019-07-23
59414	SUPPL	2019-07-23
47557	SUPPL	2017-03-14
47539	SUPPL	2017-03-13
33313	SUPPL	2016-05-11
654	SUPPL	2016-05-11
33312	SUPPL	2013-03-26
653	SUPPL	2013-03-26
13863	SUPPL	2008-07-30
11039	SUPPL	2008-07-29
11038	SUPPL	2007-09-26
652	SUPPL	2007-09-25
13862	SUPPL	2007-04-25
40753	SUPPL	2007-04-11
13860	SUPPL	2006-03-23
11036	SUPPL	2006-03-14
13861	SUPPL	2006-01-30
11037	SUPPL	2006-01-25
33311	SUPPL	2004-11-16
13859	SUPPL	2004-11-16
11035	SUPPL	2004-11-16
651	SUPPL	2004-11-16
650	SUPPL	2003-05-29