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ANAPROX	NAPROXEN SODIUM	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018164-001	ANAPROX	NAPROXEN SODIUM	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`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N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`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 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	N018164-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018164-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018164-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018164-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018164-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018164-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018164-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018164-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018164-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018164-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018164-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018164-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018164-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018164-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018164-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018164-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018164-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018164-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018164-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018164-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018164-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018164-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018164-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018164-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018164-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018164-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018164-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018164-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018164-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018164-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018164-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018164-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018164-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018164-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018164-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018164-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018164-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018164-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018164-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018164-003	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 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	efe4352f-856b-4ada-8bd4-0a78423447dc	2026-02-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	L.N.K. International, Inc.	717518e4-2537-4229-b765-c6acfe963d4b	2026-02-25	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	PHOENIX RX LLC	47d18804-d8d6-8248-e063-6394a90a48a9	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Better Living Brands, LLC	3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041	2026-02-13	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	369911ea-9069-9c45-e063-6394a90a5ce6	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	36996557-3227-b753-e063-6394a90a7b6f	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Topcare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	7f1cda40-9a67-4de1-af56-ab881c6354c4	2026-02-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	H E B	2f9439bb-e808-4c54-ba61-f75f117c8b37	2026-02-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
Back and Muscle Pain	NAPROXEN SODIUM	Rite Aid Corporation	e162bd50-f94a-4c76-8f1b-62114f283809	2026-02-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Padagis Israel Pharmaceuticals Ltd	cdb60f74-ce23-4015-90eb-b23a2275f6cb	2026-02-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	A-S Medication Solutions	8181bb7a-d917-4388-bcb0-a74671b07b06	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	83dd8829-7ba0-4a8d-a979-41a5e077c49f	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
topcare back and muscle pain	NAPROXEN SODIUM	Topco Associates LLC	de587e8f-38f2-4e7a-8e6a-64e48f280c4f	2026-02-07	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	db87d1da-8507-4bbf-aefc-3dbd48cde26b	2026-02-05	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	4a05ca8c-1b03-fa86-e063-6394a90a4119	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Rugby All Day Relief	NAPROXEN SODIUM	Bryant Ranch Prepack	3238dfdc-82d1-4afb-b27c-0ba0a5d24744	2026-02-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	6bc74cda-458c-480e-a33c-d2ba68d5e6bd	2026-01-29	Warnings	Name fallback generic name: NAPROXEN SODIUM
Care One Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	bc5ddcf2-640c-4683-a60f-ca1c8b418873	2026-01-29	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	1c2325f7-1d65-429d-a64d-6ab075df1c20	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Flanax Menstrual Pain Reliever	NAPROXEN SODIUM	Belmora LLC	2b4135b3-389c-46e2-ae86-7674c2ab9a32	2026-01-27	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