Application 018164

Type: NDA
Sponsor: ATNAHS PHARMA US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANAPROX	NAPROXEN SODIUM	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ANAPROX DS	NAPROXEN SODIUM	TABLET;ORAL	EQ 500MG BASE	Yes	Yes

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
N018164-001	ANAPROX	NAPROXEN SODIUM	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018164-003	ANAPROX DS	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018164-003	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018164-001	ANAPROX	EQ 250MG BASE	TABLET / ORAL		RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018164-001	ANAPROX	EQ 250MG BASE	TABLET / ORAL		RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N018164-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018164-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018164-003	AB	1	`a50c72e98297…`

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 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	f6f4a670-235e-4235-84a8-a74dc8ca5586	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	2794b60d-d09b-4115-9ff2-07ff15524e78	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36ce5cd9-8c61-4ed9-b840-c29ad98bdfc5	2026-08-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	L.N.K. International, Inc.	82412133-c11a-4905-a119-965f44de10b7	2026-08-17	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	27938b08-ff37-4587-aa81-5ec3ef21a28a	2026-08-12	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	38543976-ccbe-4af9-b01d-ae102452d418	2026-08-12	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	bee7b482-8ba5-411d-90ee-de00df50d2b7	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e9eb8c40-85d9-4c8e-9523-a21d3591260f	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Artridol	NAPROXEN SODIUM	Zapotol Products Corp	c422d300-3f4e-4121-8eaf-56683911b884	2026-08-05	Warnings	Name fallback generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals Inc.	2183df53-ac90-4d43-8a5d-8421036bc4cb	2026-07-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	20eb9d9f-11df-464f-a1b0-949f8fda4042	2026-07-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	d2b1eedb-2be0-42af-ba0b-9da98560c91e	2026-07-24	Warnings	Name fallback generic name: NAPROXEN SODIUM
Back and Muscle Pain	NAPROXEN SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4039504c-e612-4503-854a-62ee06780956	2026-07-13	Warnings	Name fallback generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	H E B	b5dcf3df-2628-49c7-9d96-64886bebe631	2026-07-13	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c28c4fd2-1428-421c-b62f-265e472d833e	2026-07-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	ScieGen Pharmaceuticals, Inc.	79f48c92-783d-40f2-9865-89958a9f9de6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Aleve Caplets	NAPROXEN SODIUM	Select Consumer Group	3ca84972-f8c9-1881-e063-6294a90a9070	2026-07-03	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Lidl US LLC	3d01220c-c5ec-4604-8cef-9ecb807ccd53	2026-06-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	134e5ec6-c42a-43b6-adf2-2d7546875ead	2026-06-19	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Headache Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	6161b881-f422-47ae-86ba-a28d669bce79	2026-06-18	Warnings	Name fallback generic name: NAPROXEN SODIUM

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42494-400	NAPROXEN SODIUM DS	naproxen sodium	Cameron Pharmaceuticals, LLC	NDA	Current
42494-402	NAPROXEN SODIUM	naproxen sodium	Cameron Pharmaceuticals, LLC	NDA	Current
69437-203	Anaprox DS	naproxen sodium	Canton Laboratories	NDA	Current
69437-203	Anaprox DS	naproxen sodium	Canton Laboratories	NDA	Current
69437-203	Anaprox DS	naproxen sodium	Canton Laboratories	NDA	Current
69437-203	Anaprox DS	naproxen sodium	Canton Laboratories	NDA	Current
69784-550	NAPROXEN SODIUM DS	naproxen sodium	Woodward Pharma Services LLC	NDA	Current
69784-550	NAPROXEN SODIUM DS	naproxen sodium	Woodward Pharma Services LLC	NDA	Current
69784-550	NAPROXEN SODIUM DS	naproxen sodium	Woodward Pharma Services LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80352	SUPPL	2024-11-25
80293	SUPPL	2024-11-22
80292	SUPPL	2024-11-22
78459	SUPPL	2024-05-14
78458	SUPPL	2024-05-14
67281	SUPPL	2021-04-30
67280	SUPPL	2021-04-30
67237	SUPPL	2021-04-29
59429	SUPPL	2019-07-23
59428	SUPPL	2019-07-23
59415	SUPPL	2019-07-23
47560	SUPPL	2017-03-14
47537	SUPPL	2017-03-13
14941	SUPPL	2016-05-11
11178	SUPPL	2016-05-11
14940	SUPPL	2013-03-26
11177	SUPPL	2013-03-26
869	SUPPL	2008-07-30
11176	SUPPL	2008-07-29
33454	SUPPL	2007-09-26
868	SUPPL	2007-09-25
14939	SUPPL	2007-04-25
867	SUPPL	2006-03-23
33452	SUPPL	2006-03-14
14938	SUPPL	2006-01-30
33453	SUPPL	2006-01-25
44021	ORIG	2005-07-28
33451	SUPPL	2004-11-16
33450	SUPPL	2004-11-16
866	SUPPL	2004-11-16
865	SUPPL	2004-11-16
864	SUPPL	2003-05-29