Application 074789

Type: ANDA
Sponsor: CONTRACT PHARMACAL

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
A074789-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1997-02-27

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	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074789-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074789-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`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 12 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flanax Pain Reliever/Fever Reducer	NAPROXEN SODIUM	Navajo Manufacturing Company Inc.	f706b406-58f2-9b82-e053-6394a90ab598	2023-03-16	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	a359c47e-e2b4-5560-e053-2a95a90a2844	2023-03-03	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Navajo Manufacturing Company Inc	60637aeb-deb6-4747-e053-2a91aa0ad00b	2023-03-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Granules India Ltd	95ba1722-60ed-4a83-9f26-50c4de8cf180	2023-02-06	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Belmora Flanax	NAPROXEN SODIUM	Unifirst First Aid Corporation	8591ca57-04ee-5053-e053-2991aa0aa4dd	2023-01-10	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	KROGER COMPANY	7487e685-ea64-43a2-9a4e-f5278840be04	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Wal-Mart Stores, Inc.	073ecef7-f5b1-4ee0-98bc-82972e3d84f9	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	a13bd208-f29f-1cbc-e053-2995a90a08ba	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	HEB	df8ea301-c48b-4da4-9e8e-5c69cac6cba7	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	TOP CARE (Topco Associates LLC)	c62b7fa0-5ae9-276c-e053-2995a90ade25	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION INC.	c482db41-b115-c24f-e053-2a95a90a2947	2022-12-21	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	Camber Consumer Care Inc	d1008e19-ff0d-4ed2-909d-bae5a82a1234	2022-11-23	Warnings	Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Care One (American Sales Company)	043f7032-4e83-4642-93a8-6c09de26b43f	2022-11-21	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de03311d-fb58-43f5-a110-aac9a39c9132	2022-11-07	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	a90bfc07-d01e-427c-b2df-41bff7612d2f	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	e668c80f-dd53-4b82-8678-5e4fccb13023	2022-05-02	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
betr headache pain relief	NAPROXEN SODIUM	Live Betr LLC	eaf6d2fc-ebcb-4d11-8e3f-a494f0f7920b	2022-04-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	a380cace-43dc-4b9c-84d3-0b38241d9d2e	2022-03-30	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	462a7e41-b899-4e08-8113-b48ece0ad8d8	2022-03-17	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	DISCOUNT DRUG MART, INC.	b00c0e86-4c0b-45bf-948f-824ea0f09e39	2022-03-16	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.