Application 091353

Type: ANDA
Sponsor: GRANULES INDIA

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 42.

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
A091353-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-09-20

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`e64feba35796…`

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rapidol Naproxen	NAPROXEN SODIUM	Pharmadel LLC	c94c4b6e-a48b-cee5-e053-2995a90a49ac	2026-03-20	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353 ndc (product): 55758-048
Naproxen Sodium	NAPROXEN SODIUM	Granules USA, Inc.	8cb8030c-b281-315c-e053-2a95a90a36f0	2025-12-22	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen	NAPROXEN	Safeway, Inc	f2a273f8-d623-dc2f-e053-2995a90a0c02	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc	f2a297c2-3898-5e47-e053-2995a90ab3cc	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	TARGET CORPORATION	fdb87abd-3176-dd62-e053-6394a90a6fcc	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	CVS	1042b202-e8ee-1839-e063-6294a90ac90b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	CVS	10429d07-de96-5542-e063-6294a90a7371	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Dr Simi All Day Pain Relief	NAPROXEN SODIUM	Farmacias De Similares TX LLC	3c6d4bb5-eb6f-944b-e063-6294a90ae8de	2025-08-15	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Bi-Mart	6d5cecc9-5095-477b-bfc7-45b6e7e689f0	2025-03-01	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
NAPROXEN SODIUM	NAPROXEN SODIUM	SPIRIT PHARMACEUTICALS,LLC	a690dc39-95f2-4853-a291-05d7dc9a1551	2024-12-30	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Pain Relief	NAPROXEN SODIUM	Gobrands, Inc	ae4bfa8c-ae41-4fcd-b584-872cc4d37683	2024-12-20	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
PROXEN NP 660	NAPROXEN SODIUM	OPMX LLC	09990b2f-202e-b4df-e063-6394a90a055b	2023-12-27	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Granules India Ltd	95ba1722-60ed-4a83-9f26-50c4de8cf180	2023-02-06	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353 ndc (product): 62207-327 ndc (product): 62207-761 ndc (product): 62207-729 ndc (product): 62207-328 ndc (product): 62207-728 ndc (product): 62207-762
All Day Pain Relief	NAPROXEN SODIUM TABLETS, 220 MG	HealthLife of USA LLC	7b0cb91e-5465-40ef-9f82-919f7d984f17	2017-06-01	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-055	Naproxen Sodium	Naproxen Sodium	The Kroger Co.	ANDA	Current
36800-055	Naproxen Sodium	Naproxen Sodium	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-055	Naproxen Sodium	Naproxen Sodium	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-256	All Day Pain Relief	Naproxen Sodium	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-256	All Day Pain Relief	Naproxen Sodium	TOP CARE (Topco Associates LLC)	ANDA	Current
42961-209	Xpect Naproxen Sodium	Naproxen Sodium	Cintas Corporation	ANDA	Current
46994-665	NAPROXEN SODIUM	NAPROXEN SODIUM	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-665	NAPROXEN SODIUM	NAPROXEN SODIUM	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
49035-255	Naproxen Sodium	Naproxen Sodium	EQUATE (Walmart Stores, Inc.)	ANDA	Current
49035-255	Naproxen Sodium	Naproxen Sodium	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-761	Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores, Inc.,	ANDA	Current
49035-762	Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores, Inc.,	ANDA	Current
49781-100	Naproxen Sodium	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-100	Naproxen Sodium	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-101	All Day	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-101	All Day	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
50090-5538	Naproxen Sodium	Naproxen Sodium	A-S Medication Solutions	ANDA	Current
53329-678	Naproxen Sodium 220mg	Naproxen Sodium	Medline Industries	ANDA	Current
53329-678	Naproxen Sodium 220mg	Naproxen Sodium	Medline Industries	ANDA	Current
53329-678	Naproxen Sodium 220mg	Naproxen Sodium	Medline Industries, LP	ANDA	Current
53329-678	Naproxen Sodium 220mg	Naproxen Sodium	Medline Industries, LP	ANDA	Current
53943-728	Naproxen Sodium	Naproxen Sodium	DISCOUNT DRUG MART	ANDA	Current
53943-728	Naproxen Sodium	Naproxen Sodium	DISCOUNT DRUG MART	ANDA	Current
55315-255	All Day Pain Relief	Naproxen Sodium	Freds Inc	ANDA	Current
55315-256	All Day Pain Relief	Naproxen Sodium	Freds Inc	ANDA	Current
55315-991	Naproxen Sodium	Naproxen Sodium	FREDS INC	ANDA	Current
55315-992	Naproxen Sodium	Naproxen Sodium	FREDS INC	ANDA	Current
55319-255	Naproxen Sodium	Naproxen Sodium	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-255	Naproxen Sodium	Naproxen Sodium	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-255	Naproxen Sodium	Naproxen Sodium	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-256	Naproxen Sodium	Naproxen Sodium	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-256	Naproxen Sodium	Naproxen Sodium	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-256	Naproxen Sodium	Naproxen Sodium	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-761	Naproxen Sodium	Naproxen Sodium	FAMILY DOLLAR	ANDA	Current
55319-761	Naproxen Sodium	Naproxen Sodium	FAMILY DOLLAR	ANDA	Current
55319-761	Naproxen Sodium	Naproxen Sodium	FAMILY DOLLAR	ANDA	Current
55319-762	Naproxen Sodium	Naproxen Sodium	FAMILY DOLLAR	ANDA	Current
55319-762	Naproxen Sodium	Naproxen Sodium	FAMILY DOLLAR	ANDA	Current
55319-762	Naproxen Sodium	Naproxen Sodium	FAMILY DOLLAR	ANDA	Current
55758-048	Rapidol Naproxen	Naproxen sodium	Pharmadel LLC	ANDA	Current
55758-048	Rapidol Naproxen	Naproxen sodium	Pharmadel LLC	ANDA	Current
55758-048	Rapidol Naproxen	Naproxen sodium	Pharmadel LLC	ANDA	Current
55758-320	Rapidol Naproxen	Naproxen sodium	Pharmadel LLC	ANDA	Current
55758-320	Rapidol Naproxen	Naproxen sodium	Pharmadel LLC	ANDA	Current
55758-320	Rapidol Naproxen	Naproxen sodium	Pharmadel LLC	ANDA	Current
59726-023	All Day Pain Relief	Naproxen Sodium	P & L Development, LLC	ANDA	Current
59726-256	All Day Pain Relief	Naproxen Sodium	P & L Development, LLC	ANDA	Current
59726-256	All Day Pain Relief	Naproxen Sodium	P & L Development, LLC	ANDA	Current
59726-256	All Day Pain Relief	Naproxen Sodium	P & L Development, LLC	ANDA	Current
61010-4410	Naproxen	Naproxen Sodium	Safetec of America, Inc.	ANDA	Current
62207-327	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-327	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-328	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-328	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-728	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-728	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-728	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-728	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-729	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-729	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-729	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-729	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-750	Naproxen Sodium	Naproxen Sodium	Granules India Limited	ANDA	Current
62207-753	Naproxen Sodium	Naproxen Sodium	Granules India Limited	ANDA	Current
62207-761	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-761	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-761	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-761	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-762	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-762	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-762	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-762	Naproxen Sodium	Naproxen Sodium	Granules India Ltd	ANDA	Current
63940-761	Naproxen Sodium	Naproxen Sodium	HARMON STORES INC.	ANDA	Current
63940-761	Naproxen Sodium	Naproxen Sodium	HARMON STORES INC.	ANDA	Current
63940-763	Naproxen Sodium	Naproxen Sodium	HARMON STORES INC.	ANDA	Current
63940-763	Naproxen Sodium	Naproxen Sodium	HARMON STORES INC.	ANDA	Current
68016-660	Naproxen Sodium	Naproxen Sodium	Pharmacy Value Alliance, LLC	ANDA	Current
68016-660	Naproxen Sodium	Naproxen Sodium	Pharmacy Value Alliance, LLC	ANDA	Current
68016-660	Naproxen Sodium	Naproxen Sodium	Pharmacy Value Alliance, LLC	ANDA	Current
68016-661	Naproxen Sodium	Naproxen Sodium	Pharmacy Valuce Alliance, LLC	ANDA	Current