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 3 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Northwind Health Company, LLC	fb07a76b-98ce-85dd-e053-6294a90aa6a8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	ab6ec2c9-5df9-346c-e053-2a95a90ac81d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	db478961-d984-7c8e-e053-2995a90a8a12	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	c986ba9a-6f48-8347-e053-2a95a90aa1c1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	QPharma, Inc.	307aa67f-53b9-4c60-a328-091bbf6338d4	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Safeway, Inc	f2a273f8-d623-dc2f-e053-2995a90a0c02	2025-12-19	Warnings	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Sunrise Pharmaceutical, Inc.	f2fb222a-b854-4e6f-9027-2e08aed24185	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Granules Pharmaceuticals Inc.	c1cb9bb9-fbae-5e5c-e053-2995a90a0d21	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
NAPROXEN	NAPROXEN	QPharma Inc	c0a4839b-7154-c82c-e053-2a95a90a7e6d	2025-12-03	Warnings	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	PHOENIX RX LLC	43912294-77c9-eda8-e063-6394a90adf0a	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	8c3398bd-66b1-4a14-8aaa-e4a2d6749a08	2025-11-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Medcore LLC	129392c8-8ce1-4b78-8863-042db880095f	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
NAPROXEN	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	a9f9ce81-9d51-4167-9581-974866a8fe31	2025-10-17	Warnings	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	e0f430fd-4511-41c8-b5e9-894abe4f3c37	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	cfa88511-40bb-4658-b606-44c68d0746b7	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	b500bdba-946a-41ff-855c-1f2937547d01	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Aurobindo Pharma Limited	570974d4-0d5b-4df2-b307-37380511835d	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	2d01e583-670a-46f4-b5f2-3fad46d0376f	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	124af155-0661-4054-9800-de547d8212d7	2025-09-17	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