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 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
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 · 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	A074480-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074480-002	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1998-02-18	`84e616aacf4f…`
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…`

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 5 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	2ee83008-c012-48d6-9479-65e7d6f50f4c	2025-12-10	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36bf8594-9303-c816-e063-6294a90af705	2025-12-08	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC	c69f4926-c5cd-63a0-e053-2a95a90a2ca6	2025-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	00ef5b30-71d0-4cb4-84a3-48c67d1cea2a	2025-12-04		Name fallback generic name: NAPROXEN SODIUM
Aleve Back and Muscle Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	6376e1b8-52c4-0519-e053-2a91aa0af35f	2025-12-04		Name fallback generic name: NAPROXEN SODIUM
Aleve Caplets	NAPROXEN SODIUM	Bayer HealthCare LLC.	a3745850-3e32-4884-b315-161bcb9996ed	2025-12-04		Name fallback generic name: NAPROXEN SODIUM
Aleve Gelcaps	NAPROXEN SODIUM	Bayer HealthCare LLC.	acea54a2-5a92-428e-a778-bb4f9d676782	2025-12-04		Name fallback generic name: NAPROXEN SODIUM
Aleve Gelcaps	NAPROXEN SODIUM	Bayer HealthCare LLC.	0ad8bbb9-dd5f-4273-b085-ee3e5ed22613	2025-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3c0ddd25-5a9a-4628-a971-65fe2a9775b5	2025-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	1266393e-b55e-4e34-9710-0b87209f4158	2025-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3b5442c6-c6e1-4df3-8cec-40bbb4ec469f	2025-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Granules India Ltd	1f8da545-bcfe-4c22-a9f1-d34108120aa0	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
CAREALL Naproxen	NAPROXEN SODIUM	New World Imports, Inc.	d9a0c6e7-a70e-479a-9737-e81a2887c778	2025-12-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
CAREALL Naproxen Sodium	NAPROXEN SODIUM	New World Imports, Inc.	3952324e-77f4-4117-a97a-ab5651130058	2025-12-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Upsher-Smith Laboratories, LLC	7c22a2d6-821c-4f83-aead-e756aed930e5	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
up and up naproxen sodium	NAPROXEN SODIUM	Target Corporation	b0e98603-94e9-474a-88a0-22042f461271	2025-11-19	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	0e7697ad-25c6-4405-9f9b-791633cb1ef7	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	3bd60171-c073-441a-8d59-c85efee69e07	2025-11-17	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	R J General Corporation	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	2025-11-17	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Athlete's Needs Inc	d5984c9d-3941-45d6-8392-87564b2faae0	2025-11-15	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.

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