Application 074661

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	220MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074661-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1997-01-13

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`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 1 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals Inc.	2183df53-ac90-4d43-8a5d-8421036bc4cb	2026-07-28	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	d2b1eedb-2be0-42af-ba0b-9da98560c91e	2026-07-24	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	b5dcf3df-2628-49c7-9d96-64886bebe631	2026-07-13	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5146d73-2f34-4dfe-ac29-97071279dc4d	2026-05-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Berkley and Jensen Naproxen Sodium	NAPROXEN SODIUM	BJWC	9530b649-3e01-452c-99a6-cff47fa4085b	2026-05-21	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661 ndc (product): 68391-368
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	8e150c00-8e5b-40b4-a964-cb70442c2752	2026-05-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
equaline naproxen sodium	NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	89c02e55-fa08-4001-96fc-8a01e7e74d5a	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
all day relief	NAPROXEN SODIUM	Publix Super Markets Inc	0f8843be-50a3-442c-9016-d9da3b444f60	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661 ndc (product): 56062-490
rugby all day relief	NAPROXEN SODIUM	Rugby Laboratories	f587a428-291c-4c54-80fe-244a961b0521	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	efe4352f-856b-4ada-8bd4-0a78423447dc	2026-02-27	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661 ndc (product): 69842-811
Topcare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	7f1cda40-9a67-4de1-af56-ab881c6354c4	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	2f9439bb-e808-4c54-ba61-f75f117c8b37	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Padagis Israel Pharmaceuticals Ltd	cdb60f74-ce23-4015-90eb-b23a2275f6cb	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
topcare back and muscle pain	NAPROXEN SODIUM	Topco Associates LLC	de587e8f-38f2-4e7a-8e6a-64e48f280c4f	2026-02-07	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	db87d1da-8507-4bbf-aefc-3dbd48cde26b	2026-02-05	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Rugby All Day Relief	NAPROXEN SODIUM	Bryant Ranch Prepack	3238dfdc-82d1-4afb-b27c-0ba0a5d24744	2026-02-04	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	6bc74cda-458c-480e-a33c-d2ba68d5e6bd	2026-01-29	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Care One Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	bc5ddcf2-640c-4683-a60f-ca1c8b418873	2026-01-29	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	dbf007f5-c792-43a7-8cc1-bfa617f3a7fa	2026-01-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661 ndc (product): 70000-0171
naproxen sodium	NAPROXEN SODIUM	Meijer Distribution Inc	f4e57560-ae89-4fc3-a66b-ebf3dc3f2448	2026-01-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661

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 4 of 5 · 328 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
56062-490	all day relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
56062-490	all day relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
56062-490	all day relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
59779-797	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
59779-797	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
59779-797	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
59779-797	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
59779-797	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
59779-914	naproxen sodium	Naproxen sodium	CVS Pharmacy	ANDA	Current
59779-914	naproxen sodium	Naproxen sodium	CVS Pharmacy	ANDA	Current
59779-914	naproxen sodium	Naproxen sodium	CVS Pharmacy	ANDA	Current
59779-914	naproxen sodium	Naproxen sodium	CVS Pharmacy	ANDA	Current
61919-388	NAPROXEN SODIUM	NAPROXEN SODIUM	DIRECT RX	ANDA	Current
61919-388	NAPROXEN SODIUM	NAPROXEN SODIUM	DIRECT RX	ANDA	Current
61919-388	NAPROXEN SODIUM	NAPROXEN SODIUM	DIRECT RX	ANDA	Current
62011-0017	Health Mart Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
62011-0017	Health Mart Naproxen Sodium	Naproxen Sodium	McKesson	ANDA	Current
62011-0017	Health Mart Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
62011-0017	Health Mart Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
63187-104	good sense all day pain relief	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63187-596	Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63187-596	Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63187-596	Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63187-596	Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63187-794	Good Sense Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63187-794	Good Sense Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
63981-368	kirkland signature naproxen sodium	Naproxen Sodium	Costco Wholesale Company	ANDA	Current
63981-368	kirkland signature naproxen sodium	Naproxen Sodium	Costco Wholesale Company	ANDA	Current
63981-368	kirkland signature naproxen sodium	Naproxen Sodium	Costco Wholesale Company	ANDA	Current
63981-368	kirkland signature naproxen sodium	Naproxen Sodium	Costco Wholesale Company	ANDA	Current
64725-0490	Naproxen Sodium	Naproxen Sodium	TYA Pharmaceuticals	ANDA	Current
66267-343	Naproxen Sodium	Naproxen Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
66336-002	good sense all day pain relief	Naproxen Sodium	Dispensing Solutions, Inc.	ANDA	Current
68071-4277	Good Sense Naproxen Sodium	Naproxen Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5287	Naproxen Sodium	Naproxen Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5287	Naproxen Sodium	Naproxen Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68196-368	members mark naproxen sodium	Naproxen Sodium	Sam's West Inc	ANDA	Current
68196-368	members mark naproxen sodium	Naproxen Sodium	Sam's West Inc	ANDA	Current
68196-368	members mark naproxen sodium	Naproxen Sodium	Sam's West Inc	ANDA	Current
68391-368	Berkley and Jensen Naproxen Sodium	Naproxen Sodium	BJWC	ANDA	Current
68391-368	Berkley and Jensen Naproxen Sodium	Naproxen Sodium	BJWC	ANDA	Current
68391-368	Berkley and Jensen Naproxen Sodium	Naproxen Sodium	BJWC	ANDA	Current
68788-6406	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6406	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8987	rugby all day relief	Naproxen Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
69842-010	naproxen sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-010	naproxen sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-010	naproxen sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-010	naproxen sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-811	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-811	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-811	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-811	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
70000-0171	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health	ANDA	Current
70000-0171	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0171	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0171	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0171	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health	ANDA	Current
70000-0171	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0201	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health	ANDA	Current
70000-0201	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0201	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health	ANDA	Current
70000-0201	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0201	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0201	Leader All Day Pain Relief	Naproxen Sodium	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70925-368	Humana Pharmacy All Day Pain Relief	Naproxen Sodium	Humana Pharmacy, Inc.	ANDA	Current
70925-368	Humana Pharmacy All Day Pain Relief	Naproxen Sodium	Humana Pharmacy, Inc.	ANDA	Current
70934-247	Naproxen Sodium	Naproxen Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-247	Naproxen Sodium	Naproxen Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-425	Naproxen Sodium	Naproxen Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-425	Naproxen Sodium	Naproxen Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71141-008	Naproxen Sodium	Naproxen Sodium	Lidl US LLC	ANDA	Current
71141-008	Naproxen Sodium	Naproxen Sodium	Lidl US LLC	ANDA	Current
71335-1061	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1061	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
72189-003	Naproxen Sodium	Naproxen Sodium	Direct_Rx	ANDA	Current
72189-003	Naproxen Sodium	Naproxen Sodium	Direct_Rx	ANDA	Current
72189-003	Naproxen Sodium	Naproxen Sodium	Direct_Rx	ANDA	Current
72189-003	Naproxen Sodium	Naproxen Sodium	Direct_Rx	ANDA	Current
72288-331	Basic Care Naproxen Sodium	Naproxen Sodium	Amazon.com Services LLC	ANDA	Current