Application 074257

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	EQ 250MG BASE	No	No
002	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	EQ 500MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074257-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL			1993-12-21
A074257-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL			1993-12-21

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 3 · 86 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	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074257-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1993-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074257-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1993-12-21	`74a2ff9319b5…`

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 8 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium BACK AND MUSCLE PAIN	NAPROXEN SODIUM	Aurohealth LLC	666e3c6a-e571-4124-84d8-0142db1012dc	2025-05-26	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Aurohealth LLC	d570f8f3-88b8-408d-8d20-3ca5f64c81f8	2025-05-23	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Aurohealth LLC	46a15412-25d6-454d-86db-70321d19a2c9	2025-05-23	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WALMART INC.	1292c0ca-343e-adcc-e063-6394a90ab9fa	2025-05-23	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium HEADACHE PAIN	NAPROXEN SODIUM	Aurohealth LLC	e4a9ea0e-aec4-493c-b9b4-5e5a91d260d5	2025-05-23	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium BACK AND MUSCLE PAIN	NAPROXEN SODIUM	Aurohealth LLC	c2066fce-cfa2-426d-ab6d-1a426736612b	2025-05-23	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WALMART INC.	09b52dd4-0434-237c-e063-6294a90ab9b5	2025-05-23	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	04245a78-228e-439f-8ffb-9d9bc56c7bb7	2025-05-20	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	c1dce2e4-ad7a-4462-a775-9a5bcb2375ed	2025-05-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	a0c67043-1e78-4eac-86e6-497b4364651a	2025-05-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	Walmart Inc.	32df7378-4dd1-4f7e-e063-6394a90ad948	2025-05-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	AAFES/Your Military Exchanges	c387f7cb-7cc4-4989-9f9a-bb00a895fd0d	2025-05-08	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	Meijer Distribution Inc	72f461bc-621e-4e2b-b437-53a580125f3c	2025-05-02	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
basic care naproxen sodium	NAPROXEN SODIUM	Amazon.com Services LLC	29fc5a16-49ed-41ca-a296-bee34d1d12f6	2025-04-17	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Caplets - Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	94f09ef7-0695-4499-83c1-95f1e42baf98	2025-04-10	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	31bad2d9-c0bb-7f20-e063-6294a90acb17	2025-04-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Back and Muscle Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	31bae77b-42dd-94eb-e063-6294a90ad570	2025-04-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	31baf777-c805-21ea-e063-6394a90abbd8	2025-04-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	3d57ba5c-3a1d-435a-aa4f-9cc709e1b8cf	2025-03-28	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
rugby all day relief	NAPROXEN SODIUM	A-S Medication Solutions	369f5123-283d-4aa6-8861-8d183f2ba94d	2025-03-18	Warnings	Name fallback generic name: NAPROXEN SODIUM

Reported adverse events (FAERS/openFDA)#

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