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ANAPROX	NAPROXEN SODIUM	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018164-001	ANAPROX	NAPROXEN SODIUM	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`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N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`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 6 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
up and up naproxen sodium	NAPROXEN SODIUM	Target Corporation	00bd8490-f280-4336-b13d-0e11c0bf4586	2025-11-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Rugby All Day Relief	NAPROXEN SODIUM	Rugby Laboratories	16e107f0-45a3-428f-b849-0f20a848a602	2025-10-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	b01c2b4e-a092-42dc-a387-d181d8ba14bb	2025-10-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Better Living Brands, LLC	43745d42-f859-4168-a2dd-2c8ae47ae590	2025-10-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
CALMADOL PAIN RELIEVER	NAPROXEN SODIUM	GRANDALL DISTRIBUTING, LLC	8edec8d1-a323-436b-8329-c327438516e3	2025-10-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	b6205032-f5c6-494a-8b87-adbbbc3982e7	2025-10-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Amerisource Bergen	1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0	2025-10-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
First Aid Direct All Day Pain Relief	NAPROXEN SODIUM	Cintas Corporation	1c9384c1-52f8-4482-88fc-5f5b6d770c42	2025-09-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
foster and thrive all day pain relief	NAPROXEN SODIUM	Strategic Sourcing Services LLC	01746bb6-4068-4737-ba38-04cd5f1a81ba	2025-09-12	Warnings	Name fallback generic name: NAPROXEN SODIUM
Bayer Aleve	NAPROXEN SODIUM	Unifirst First Aid Corporation	5dd569ca-d03e-410c-af98-4732c823d595	2025-09-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
Medique at Home Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	b591ba4f-d7d3-4c81-e053-2995a90a7c6e	2025-09-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	f6261d45-df1f-483b-b013-3cd6f78d9d43	2025-09-08	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Aurobindo Pharma Limited	37b264f9-b46d-4635-8fab-246b1e08b653	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e5e8768d-c6e0-4018-b788-5ce86929f7b0	2025-08-26	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium PM	NAPROXEN SODIUM	Strategic Sourcing Services LLC	03a331d8-c957-4949-894f-51d9bd15e0d0	2025-08-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	fc65fe79-c93b-4247-b9af-e562792a3e64	2025-08-19	Warnings	Name fallback generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	Safeway	396f4e60-3dde-433f-b4b5-25f351c96d57	2025-08-19	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	6ae413ba-5a48-423f-8b8d-7a42661cf836	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Dr Simi All Day Pain Relief	NAPROXEN SODIUM	Farmacias De Similares TX LLC	3c6d4bb5-eb6f-944b-e063-6294a90ae8de	2025-08-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	3ba28e47-1294-bec7-e063-6294a90ac80a	2025-08-05	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