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 10 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
exchange select naproxen sodium	NAPROXEN SODIUM	Army & Air Force Exchange Service	5294f434-62c2-4393-9c9e-c94dd9a19687	2024-12-07	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WinCo Foods, LLC	44ef3ef4-9495-4a63-92f0-f0ab19c4ec23	2024-12-06	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WinCo Foods, LLC	074fc2b9-743b-458e-a0c0-d5f27633bbf3	2024-12-06	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	48059718-4e35-479c-a549-ac534d3ba899	2024-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	593b915f-045a-40b7-b86e-0d1cb41f2bb8	2024-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Teva Pharmaceuticals, Inc.	826fd9e3-22fe-408b-820c-f2b710189555	2024-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Belmora Flanax	NAPROXEN SODIUM	Belmora LLC	a44b8a82-251d-d5e8-e053-2a95a90a72f7	2024-10-08	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Albertsons Companies	f9df7495-9da7-8838-e053-6294a90a6fda	2024-09-30	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	42f6a3a0-5a1e-40ca-8949-b8870dd95d2e	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Alvogen Inc.	9225acaa-209f-958b-2c51-9a46995dec33	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naprelan	NAPROXEN SODIUM	Almatica Pharma LLC	e633ff0b-eab7-f167-8d08-e9236e54042b	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NAPROXEN SODIUM
Aleve liquid gels	NAPROXEN SODIUM	Bayer Healthcare LLC	a0587c73-d297-462d-a0ef-750cb324486e	2024-05-06	Warnings	Name fallback generic name: NAPROXEN SODIUM
Topcare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	f151d48d-a8f7-484e-9ce8-6b2e8dd1093f	2024-04-25	Warnings	Name fallback generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	H E B	535a6531-3372-4206-b97b-f26a16b6d80c	2024-04-25	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	AMERISOURCE BERGEN	16b3bbee-4881-b439-e063-6394a90a7c8f	2024-04-22	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Lil Drug Store Pain Relief All Day	NAPROXEN SODIUM	Lil' Drug Store Products, Inc.	41d2d995-47ef-419d-8e57-ea3f9f8a9f68	2024-03-29	Warnings	Name fallback generic name: NAPROXEN SODIUM
ALL DAY PAIN RELIEF	NAPROXEN SODIUM	WALGREENS	8771b84f-47bf-116c-e053-2995a90a0aad	2024-03-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
ALL DAY PAIN RELIEF	NAPROXEN SODIUM	WALGREENS	8771300f-e907-3d53-e053-2a95a90ae402	2024-03-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Care One (Retail Business Services, LLC.)	5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad	2024-02-21	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
good sense naproxen sodium	NAPROXEN SODIUM	L. Perrigo Company	a980b939-f74d-4e95-87a8-65ad5a783ac5	2024-02-19	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