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 6 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
up and up naproxen sodium	NAPROXEN SODIUM	Target Corporation	00bd8490-f280-4336-b13d-0e11c0bf4586	2025-11-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Rugby All Day Relief	NAPROXEN SODIUM	Rugby Laboratories	16e107f0-45a3-428f-b849-0f20a848a602	2025-10-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	b01c2b4e-a092-42dc-a387-d181d8ba14bb	2025-10-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Better Living Brands, LLC	43745d42-f859-4168-a2dd-2c8ae47ae590	2025-10-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
CALMADOL PAIN RELIEVER	NAPROXEN SODIUM	GRANDALL DISTRIBUTING, LLC	8edec8d1-a323-436b-8329-c327438516e3	2025-10-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	b6205032-f5c6-494a-8b87-adbbbc3982e7	2025-10-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Amerisource Bergen	1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0	2025-10-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
First Aid Direct All Day Pain Relief	NAPROXEN SODIUM	Cintas Corporation	1c9384c1-52f8-4482-88fc-5f5b6d770c42	2025-09-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
foster and thrive all day pain relief	NAPROXEN SODIUM	Strategic Sourcing Services LLC	01746bb6-4068-4737-ba38-04cd5f1a81ba	2025-09-12	Warnings	Name fallback generic name: NAPROXEN SODIUM
Bayer Aleve	NAPROXEN SODIUM	Unifirst First Aid Corporation	5dd569ca-d03e-410c-af98-4732c823d595	2025-09-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
Medique at Home Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	b591ba4f-d7d3-4c81-e053-2995a90a7c6e	2025-09-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	f6261d45-df1f-483b-b013-3cd6f78d9d43	2025-09-08	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Aurobindo Pharma Limited	37b264f9-b46d-4635-8fab-246b1e08b653	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e5e8768d-c6e0-4018-b788-5ce86929f7b0	2025-08-26	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium PM	NAPROXEN SODIUM	Strategic Sourcing Services LLC	03a331d8-c957-4949-894f-51d9bd15e0d0	2025-08-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	fc65fe79-c93b-4247-b9af-e562792a3e64	2025-08-19	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	Safeway	396f4e60-3dde-433f-b4b5-25f351c96d57	2025-08-19	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	6ae413ba-5a48-423f-8b8d-7a42661cf836	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Dr Simi All Day Pain Relief	NAPROXEN SODIUM	Farmacias De Similares TX LLC	3c6d4bb5-eb6f-944b-e063-6294a90ae8de	2025-08-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM 220MG	CVS Pharmacy, Inc.	1fde52e7-7a7f-40e8-e063-6394a90a922a	2025-08-11	Warnings	Name fallback brand name: Naproxen Sodium

Reported adverse events (FAERS/openFDA)#

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