Application 079096

Type: ANDA
Sponsor: AMNEAL PHARMS NY

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 1.

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
A079096-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2008-12-16

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079096-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2008-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079096-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2008-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Mediproxen	NAPROXEN SODIUM	Sportpharm LLC	f01adfcc-b32a-4a98-a4e7-2ce87b824b5a	2026-04-24	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a0c910-7dd7-6a42-e063-6394a90a491c	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a00020-173b-a4a1-e063-6294a90ae399	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	12748345-0d79-d6f8-e063-6394a90ab6c6	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	1274889d-803c-d7fd-e063-6394a90ab9a8	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	d9e72c3f-addc-4391-a7a4-2680a3e7f5c4	2025-12-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	2ee83008-c012-48d6-9479-65e7d6f50f4c	2025-12-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	27938b08-ff37-4587-aa81-5ec3ef21a28a	2025-12-09	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
CAREALL Naproxen	NAPROXEN SODIUM	New World Imports, Inc.	d9a0c6e7-a70e-479a-9737-e81a2887c778	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 51824-072
CAREALL Naproxen Sodium	NAPROXEN SODIUM	New World Imports, Inc.	3952324e-77f4-4117-a97a-ab5651130058	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique at Home Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	b591ba4f-d7d3-4c81-e053-2995a90a7c6e	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 47682-737
Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	f6261d45-df1f-483b-b013-3cd6f78d9d43	2025-09-08	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 47682-237
Naproxen Sodium	NAPROXEN SODIUM	AMERIFOODS TRADING COMPANY	f6dd2150-1643-18ff-e053-6294a90a422b	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	684e03b6-74eb-4374-a512-1c01ea216b51	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	eeda0edf-7054-42aa-af8e-4df38b918f81	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	84b9e9a4-b805-420e-83be-ebe98776d1ee	2025-06-20	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
NAPROXEN SODIUM	NAPROXEN SODIUM	AAA Pharmaceutical, Inc.	5ea3217d-845d-4781-b849-6b00babdc214	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	FSA STORE INC.	f4326f99-142b-0b70-e053-2995a90ac951	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	38543976-ccbe-4af9-b01d-ae102452d418	2025-05-21	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	04245a78-228e-439f-8ffb-9d9bc56c7bb7	2025-05-20	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 138 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0168	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0168	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0168	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0169	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0169	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0169	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
15127-168	All Day Pain Relief	Naproxen Sodium	Select Brand Dist.	ANDA	Current
15127-168	All Day Pain Relief	Naproxen Sodium	Select Brand Dist.	ANDA	Current
15127-168	All Day Pain Relief	Naproxen Sodium	Select Brand Dist.	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
30142-168	All Day Pain Relief	Naproxen Sodium	The Kroger Co.	ANDA	Current
33992-0169	All Day Pain Relief	Naproxen Sodium	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0169	All Day Pain Relief	Naproxen Sodium	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0169	All Day Pain Relief	Naproxen Sodium	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
37205-744	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 37205	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
41163-167	All Day Pain Relief	Naproxen Sodium	EQUALINE (SuperValu)	ANDA	Current
41163-167	All Day Pain Relief	Naproxen Sodium	EQUALINE (SuperValu)	ANDA	Current
41163-169	All Day Pain Relief	Naproxen Sodium	SuperValu (Equaline)	ANDA	Current
41163-169	All Day Pain Relief	Naproxen Sodium	EQUALINE (SuperValu)	ANDA	Current
42961-108	First Aid Direct Naproxen Sodium	Naproxen Sodium	Cintas Corp	ANDA	Current
47682-037	Belmora Flanax	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corpor	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
49035-068	Naproxen Sodium	Naproxen Sodium	EQUATE (Walmart Stores, Inc.)	ANDA	Current
49035-068	Naproxen Sodium	Naproxen Sodium	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49781-046	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-046	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-047	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-047	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-145	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-145	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-146	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-146	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
50090-2388	Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2388	Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2388	Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
51824-071	CAREALL Naproxen	Naproxen Sodium	New World Imports, Inc.	ANDA	Current
51824-072	CAREALL Naproxen	Naproxen Sodium	New World Imports, Inc.	ANDA	Current
53185-004	Clear Choice Naproxen Sodium	Naproxen Sodium	Athlete's Needs Inc	ANDA	Current
53329-671	Naproxen Sodium	Naproxen Sodium	Medline Industries	ANDA	Current
53329-671	Naproxen Sodium	Naproxen Sodium	Medline Industries	ANDA	Current
53329-671	Naproxen Sodium	Naproxen Sodium	Medline Industries	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53943-144	Naproxen	NAPROXEN SODIUM	DISCOUNT DRUG MART	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23929	ORIG	2009-01-06