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 4 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	dbf007f5-c792-43a7-8cc1-bfa617f3a7fa	2026-01-26	Warnings	Name fallback generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	Meijer Distribution Inc	f4e57560-ae89-4fc3-a66b-ebf3dc3f2448	2026-01-22	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a0c910-7dd7-6a42-e063-6394a90a491c	2026-01-13	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a00020-173b-a4a1-e063-6294a90ae399	2026-01-13	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naprelan	NAPROXEN SODIUM	Upsher-Smith Laboratories, LLC	b8a51c9a-488e-4377-a041-436f6a2f8893	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Flanax	NAPROXEN SODIUM	Belmora LLC	2c099d45-f03a-4161-a6af-8fe5965f2748	2026-01-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	145cdcc0-9bd5-4a0e-81fc-11a24d181980	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc.	deb1be0f-64ae-46b5-b54a-1a58eec6492e	2026-01-05	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Granules USA, Inc.	8cb8030c-b281-315c-e053-2a95a90a36f0	2025-12-22	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc	f2a297c2-3898-5e47-e053-2995a90ab3cc	2025-12-19	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	TARGET CORPORATION	fdb87abd-3176-dd62-e053-6394a90a6fcc	2025-12-19	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CVS	1042b202-e8ee-1839-e063-6294a90ac90b	2025-12-19	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CVS	10429d07-de96-5542-e063-6294a90a7371	2025-12-19	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
signature care naproxen sodium	NAPROXEN SODIUM	Safeway	85f78e63-98aa-4cf3-887d-0ac535184f97	2025-12-16	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	MEIJER DISTRIBUTION INC	89f82399-9f71-49dd-8710-b60f346c576c	2025-12-12	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	12748345-0d79-d6f8-e063-6394a90ab6c6	2025-12-11	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	1274889d-803c-d7fd-e063-6394a90ab9a8	2025-12-11	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	WALMART INC.	c4909e43-57ba-44bc-a234-a02cc884891c	2025-12-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	d9e72c3f-addc-4391-a7a4-2680a3e7f5c4	2025-12-10	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.