Application 074480

Type: ANDA
Sponsor: HIKMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074480-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL			1996-05-14
A074480-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL			1998-02-18

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`bb7c543d1eb4…`

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 1 of 13 · 258 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	27938b08-ff37-4587-aa81-5ec3ef21a28a	2026-08-12	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	38543976-ccbe-4af9-b01d-ae102452d418	2026-08-12	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	bee7b482-8ba5-411d-90ee-de00df50d2b7	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e9eb8c40-85d9-4c8e-9523-a21d3591260f	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Artridol	NAPROXEN SODIUM	Zapotol Products Corp	c422d300-3f4e-4121-8eaf-56683911b884	2026-08-05	Warnings	Name fallback generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals Inc.	2183df53-ac90-4d43-8a5d-8421036bc4cb	2026-07-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	20eb9d9f-11df-464f-a1b0-949f8fda4042	2026-07-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	d2b1eedb-2be0-42af-ba0b-9da98560c91e	2026-07-24	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Back and Muscle Pain	NAPROXEN SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4039504c-e612-4503-854a-62ee06780956	2026-07-13	Warnings	Name fallback generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	H E B	b5dcf3df-2628-49c7-9d96-64886bebe631	2026-07-13	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c28c4fd2-1428-421c-b62f-265e472d833e	2026-07-09	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	ScieGen Pharmaceuticals, Inc.	79f48c92-783d-40f2-9865-89958a9f9de6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Aleve Caplets	NAPROXEN SODIUM	Select Consumer Group	3ca84972-f8c9-1881-e063-6294a90a9070	2026-07-03	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Lidl US LLC	3d01220c-c5ec-4604-8cef-9ecb807ccd53	2026-06-22	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	134e5ec6-c42a-43b6-adf2-2d7546875ead	2026-06-19	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Headache Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	6161b881-f422-47ae-86ba-a28d669bce79	2026-06-18	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	d9c63e1f-c2ad-434b-8a21-7fff21b7477b	2026-06-03	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5146d73-2f34-4dfe-ac29-97071279dc4d	2026-05-26	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Berkley and Jensen Naproxen Sodium	NAPROXEN SODIUM	BJWC	9530b649-3e01-452c-99a6-cff47fa4085b	2026-05-21	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	181c2d5b-2c61-bf20-e063-6294a90a3f7f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9908	NAPROXEN	naproxen sodium	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9916	NAPROXEN	naproxen sodium	West-Ward Pharmaceuticals Corp	ANDA	Current
10544-614	NAPROXEN	naproxen sodium	Blenheim Pharmacal, Inc.	ANDA	Current
59115-002	Naproxen Sodium	Naproxen Sodium	Hikma Pharmaceutical	ANDA	Current
59115-002	Naproxen Sodium	Naproxen Sodium	Hikma Pharmaceutical	ANDA	Current