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ANAPROX	NAPROXEN SODIUM	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018164-001	ANAPROX	NAPROXEN SODIUM	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`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N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`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 9 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	0ac4c343-a5b6-4f69-a75a-87074dc867e8	2025-03-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	9551e84b-19bc-43e7-9c6e-0f24fdeb5abe	2025-03-03	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bi-Mart	6d5cecc9-5095-477b-bfc7-45b6e7e689f0	2025-03-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Geri-Care Pharmaceutical Corp	9a61d544-e46d-6703-e053-2a95a90a32fd	2025-02-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Relief	NAPROXEN SODIUM	Publix Super Markets Inc	688451a2-e94a-434a-8e9c-9fe3abf5c3d5	2025-02-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	2025-02-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Bryant Ranch Prepack	f9ddc614-26b7-48dc-ae93-02da6388f2d5	2025-01-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
DG Health Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp Inc	534eaf8a-0d2a-4390-af92-af5c98ba56a5	2025-01-23	Warnings	Name fallback generic name: NAPROXEN SODIUM
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	51e49a00-e040-4e7b-838c-c77ed75a7f92	2025-01-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Basic Care Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	d5c185d9-0bea-4970-b1e7-201a51106ad6	2025-01-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Direct Rx	d95279d9-6e2a-0bd6-e053-2a95a90a447d	2025-01-21		Name fallback generic name: NAPROXEN SODIUM
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	3ca9ce63-39f4-4ba9-b464-d048fd8e67c0	2025-01-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	Walgreen Company	318d4e2a-7108-4e88-8e56-5bec17ca4a3e	2025-01-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Lil' Drug Store Products, Inc	abfcf13e-6eba-49e2-8ebf-459348714270	2025-01-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	b8e417d2-3fc8-9a5e-e053-2a95a90a4155	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	SPIRIT PHARMACEUTICALS,LLC	a690dc39-95f2-4853-a291-05d7dc9a1551	2024-12-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
DG Health Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp Inc	43926764-f8d1-42b4-b55b-0524d9ff98f3	2024-12-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
Pain Relief	NAPROXEN SODIUM	Gobrands, Inc	ae4bfa8c-ae41-4fcd-b584-872cc4d37683	2024-12-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	Quality Care Products, LLC	e2ed5556-8109-4002-bf8b-827518a84ea4	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
exchange select naproxen sodium	NAPROXEN SODIUM	Army & Air Force Exchange Service	5294f434-62c2-4393-9c9e-c94dd9a19687	2024-12-07	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