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 9 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Care One Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	88812af7-89ca-449b-9513-20c284543d0e	2025-03-13	Warnings	Name fallback generic name: NAPROXEN SODIUM
CareOne Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	0ac4c343-a5b6-4f69-a75a-87074dc867e8	2025-03-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	9551e84b-19bc-43e7-9c6e-0f24fdeb5abe	2025-03-03	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bi-Mart	6d5cecc9-5095-477b-bfc7-45b6e7e689f0	2025-03-01	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Geri-Care Pharmaceutical Corp	9a61d544-e46d-6703-e053-2a95a90a32fd	2025-02-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Relief	NAPROXEN SODIUM	Publix Super Markets Inc	688451a2-e94a-434a-8e9c-9fe3abf5c3d5	2025-02-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	2025-02-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Bryant Ranch Prepack	f9ddc614-26b7-48dc-ae93-02da6388f2d5	2025-01-30	Warnings	Name fallback generic name: NAPROXEN SODIUM
DG Health Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp Inc	534eaf8a-0d2a-4390-af92-af5c98ba56a5	2025-01-23	Warnings	Name fallback generic name: NAPROXEN SODIUM
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	51e49a00-e040-4e7b-838c-c77ed75a7f92	2025-01-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Basic Care Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	d5c185d9-0bea-4970-b1e7-201a51106ad6	2025-01-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Direct Rx	d95279d9-6e2a-0bd6-e053-2a95a90a447d	2025-01-21		Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	3ca9ce63-39f4-4ba9-b464-d048fd8e67c0	2025-01-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	Walgreen Company	318d4e2a-7108-4e88-8e56-5bec17ca4a3e	2025-01-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Lil' Drug Store Products, Inc	abfcf13e-6eba-49e2-8ebf-459348714270	2025-01-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	b8e417d2-3fc8-9a5e-e053-2a95a90a4155	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	SPIRIT PHARMACEUTICALS,LLC	a690dc39-95f2-4853-a291-05d7dc9a1551	2024-12-30	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
DG Health Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp Inc	43926764-f8d1-42b4-b55b-0524d9ff98f3	2024-12-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
Pain Relief	NAPROXEN SODIUM	Gobrands, Inc	ae4bfa8c-ae41-4fcd-b584-872cc4d37683	2024-12-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	Quality Care Products, LLC	e2ed5556-8109-4002-bf8b-827518a84ea4	2024-12-18	Boxed warning, Warnings, Adverse reactions	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.