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 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
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 · 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	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`caaa826d4ba7…`
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…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	c1dce2e4-ad7a-4462-a775-9a5bcb2375ed	2025-05-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 53943-144
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	a0c67043-1e78-4eac-86e6-497b4364651a	2025-05-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	WinCo Foods, LLC	44ef3ef4-9495-4a63-92f0-f0ab19c4ec23	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	WinCo Foods, LLC	074fc2b9-743b-458e-a0c0-d5f27633bbf3	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
All Day Pain Relief	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	48059718-4e35-479c-a549-ac534d3ba899	2024-12-04	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
All Day Pain Relief	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	593b915f-045a-40b7-b86e-0d1cb41f2bb8	2024-12-04	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Lil Drug Store Pain Relief All Day	NAPROXEN SODIUM	Lil' Drug Store Products, Inc.	41d2d995-47ef-419d-8e57-ea3f9f8a9f68	2024-03-29	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	2d04fef4-6a26-4df2-af90-816107e7dfe2	2024-02-02	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 50090-2388
Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever	NAPROXEN SODIUM	Amneal Pharmaceuticals of New York LLC	0bb41b8c-6031-4e96-95e1-31adab811837	2023-12-31	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 53746-192 ndc (product): 53746-191
All Day Pain Relief	NAPROXEN SODIUM	H E B	6dd54a14-67cd-4295-9bd5-1d6f8cb9316d	2023-12-19	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 37808-068
Belmora Flanax	NAPROXEN SODIUM	Unifirst First Aid Corporation	8591ca57-04ee-5053-e053-2991aa0aa4dd	2023-01-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096 ndc (product): 47682-037

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 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