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 2 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	e6277515-c606-4535-9c29-08cade045aee	2026-05-14	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	c194124b-a5f6-423e-bc9a-7b611df990a8	2026-05-13	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	9343c79f-9994-4599-bcfe-0a93e49d726e	2026-05-12	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	8e150c00-8e5b-40b4-a964-cb70442c2752	2026-05-11	Warnings	Name fallback generic name: NAPROXEN SODIUM
equaline naproxen sodium	NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	89c02e55-fa08-4001-96fc-8a01e7e74d5a	2026-05-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
all day relief	NAPROXEN SODIUM	Publix Super Markets Inc	0f8843be-50a3-442c-9016-d9da3b444f60	2026-05-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
rugby all day relief	NAPROXEN SODIUM	Rugby Laboratories	f587a428-291c-4c54-80fe-244a961b0521	2026-05-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	04a298dc-c525-8198-e063-6294a90a6f96	2026-04-27	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Medique Mediproxen	NAPROXEN SODIUM	Sportpharm LLC	f01adfcc-b32a-4a98-a4e7-2ce87b824b5a	2026-04-24	Warnings	Name fallback generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	ba4f927a-4bbe-0d87-e053-2995a90a8c20	2026-04-20	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
Aleve	NAPROXEN SODIUM	Navajo Manufacturing Company Inc.	590f3be2-20df-4643-9114-e7ed4cf9155c	2026-04-08	Warnings	Name fallback generic name: NAPROXEN SODIUM
Rapidol Naproxen	NAPROXEN SODIUM	Pharmadel LLC	c94c4b6e-a48b-cee5-e053-2995a90a49ac	2026-03-20	Warnings	Name fallback generic name: NAPROXEN SODIUM
Aleve Caplets	NAPROXEN SODIUM	Bayer HealthCare LLC.	02941928-128a-2c88-e063-6294a90ac6ba	2026-03-12	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	d9806ad8-1cea-4599-97ef-a956ec7f0e21	2026-03-11	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Back and Muscle Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	68944663-0dc0-4d3a-a36b-019061bdbfa0	2026-03-09	Warnings	Name fallback generic name: NAPROXEN SODIUM
AnaDent	NAPROXEN SODIUM	Belmora LLC	236674db-da4d-415c-a160-7086eaf5bff5	2026-03-03	Warnings	Name fallback 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