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 ndc (product): 43063-909
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
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
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 ndc (product): 45802-490
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
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 3 of 5 · 328 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42507-368	all day relief	Naproxen Sodium	HyVee Inc	ANDA	Current
43063-909	Naproxen Sodium	Naproxen Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-909	Naproxen Sodium	Naproxen Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-909	Naproxen Sodium	Naproxen Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45802-490	Naproxen Sodium	Naproxen Sodium	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-490	Naproxen Sodium	Naproxen Sodium	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-490	Naproxen Sodium	Naproxen Sodium	Perrigo New York Inc	ANDA	Current
45802-490	Naproxen Sodium	Naproxen Sodium	Perrigo New York Inc	ANDA	Current
45865-666	naproxen sodium	Naproxen Sodium	medsource pharmaceuticals	ANDA	Current
46122-309	good neighbor pharmacy naproxen sodium	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-309	good neighbor pharmacy naproxen sodium	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46994-368	Being Well all day pain relief	Naproxen Sodium	Save-A-Lot Food Stores Ltd	ANDA	Current
46994-368	Being Well all day pain relief	Naproxen Sodium	Save-A-Lot Food Stores Ltd	ANDA	Current
49035-140	Equate Naproxen Sodium	Naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
49035-140	Equate Naproxen Sodium	Naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
49035-368	equate naproxen sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-368	equate naproxen sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-490	equate naproxen sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-490	equate naproxen sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-637	Equate Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-637	Equate Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-754	equate all day pain relief	naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
49035-754	equate all day pain relief	naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
49035-754	equate all day pain relief	naproxen sodium	Wal-Mart Stores Inc	ANDA	Current
49035-767	equate all day pain relief	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-767	equate all day pain relief	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-767	equate all day pain relief	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-767	equate all day pain relief	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49348-260	Sunmark Naproxen Sodium	Naproxen Sodium	McKesson	ANDA	Current
49348-260	Sunmark Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
49348-260	Sunmark Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
49348-306	Sunmark Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
49348-306	Sunmark Naproxen Sodium	Naproxen Sodium	Strategic Sourcing Services LLC	ANDA	Current
49348-306	Sunmark Naproxen Sodium	Naproxen Sodium	McKesson	ANDA	Current
49738-140	smart sense naproxen sodium	Naproxen sodium	Kmart Corporation	ANDA	Current
49738-368	Smart Sense Naproxen Sodium	Naproxen Sodium	Kmart Corporation	ANDA	Current
49738-368	Smart Sense Naproxen Sodium	Naproxen Sodium	Kmart Corporation	ANDA	Current
49738-490	Smart Sense naproxen sodium	Naproxen Sodium	Kmart Corporation	ANDA	Current
50090-0685	Naproxen Sodium	Naproxen Sodium	A-S Medication Solutions	ANDA	Current
50090-0685	Naproxen Sodium	Naproxen Sodium	A-S Medication Solutions	ANDA	Current
50090-0685	Naproxen Sodium	Naproxen Sodium	A-S Medication Solutions	ANDA	Current
50090-3356	rugby all day relief	Naproxen Sodium	A-S Medication Solutions	ANDA	Current
50090-3369	Good Sense Naproxen Sodium	Naproxen Sodium	A-S Medication Solutions	ANDA	Current
50436-6606	good sense all day pain relief	Naproxen Sodium	Unit Dose Services	ANDA	Current
50594-024	Sound Body Naproxen Sodium	Naproxen Sodium	Big Lots Stores, Inc.	ANDA	Current
50594-024	Sound Body Naproxen Sodium	Naproxen Sodium	Big Lots Stores, Inc.	ANDA	Current
50594-024	Sound Body Naproxen Sodium	Naproxen Sodium	Big Lots Stores, Inc.	ANDA	Current
50594-024	Sound Body Naproxen Sodium	Naproxen Sodium	Big Lots Stores, Inc.	ANDA	Current
50594-140	sound body naproxen sodium	Naproxen sodium	Big Lots Stores, Inc.	ANDA	Current
50594-140	sound body naproxen sodium	Naproxen sodium	Big Lots Stores, Inc.	ANDA	Current
51655-624	Naproxen Sodium	Naproxen Sodium	Northwind Pharmaceuticals, LLC	ANDA	Current
52959-469	all day relief	Naproxen Sodium	H.J. Harkins Company, Inc.	ANDA	Current
53002-1307	Leader All Day Pain Relief	Naproxen Sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
55301-368	exchange select naproxen sodium	Naproxen Sodium	Army & Air Force Exchange Service	ANDA	Current
55301-368	exchange select naproxen sodium	Naproxen Sodium	Army & Air Force Exchange Service	ANDA	Current
55301-368	exchange select naproxen sodium	Naproxen Sodium	Army & Air Force Exchange Service	ANDA	Current
55316-140	Healthy Accents Naproxen Sodium	Naproxen sodium	DZA Brands LLC	ANDA	Current
55316-140	Healthy Accents Naproxen Sodium	Naproxen sodium	DZA Brands LLC	ANDA	Current
55316-368	Healthy Accents All Day Pain Relief	Naproxen Sodium	DZA Brands LLC	ANDA	Current
55316-699	healthy accents naproxen sodium	Naproxen Sodium	DZA Brands LLC	ANDA	Current
55316-699	healthy accents naproxen sodium	Naproxen Sodium	DZA Brands LLC	ANDA	Current
55316-701	Healthy Accents Naproxen Sodium	Naproxen Sodium	DZA Brands LLC	ANDA	Current
55700-335	Rugby All Day Relief	Naproxen Sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-883	Good Sense Naproxen Sodium	Naproxen Sodium	Quality Care Products, LLC	ANDA	Current
55910-481	DG Health Naproxen Sodium	naproxen sodium	Dolgencorp, LLC	ANDA	Current
55910-490	DG Health Naproxen Sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-490	DG Health Naproxen Sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-490	DG Health Naproxen Sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-490	DG Health Naproxen Sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-500	dg health naproxen sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-500	dg health naproxen sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-500	dg health naproxen sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-729	dg health naproxen sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-729	dg health naproxen sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
55910-729	dg health naproxen sodium	Naproxen Sodium	Dolgencorp, LLC	ANDA	Current
56062-368	All Day Relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
56062-368	All Day Relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
56062-368	All Day Relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
56062-368	All Day Relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current
56062-490	all day relief	Naproxen Sodium	Publix Super Markets Inc	ANDA	Current