Application 076494

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	TABLET;ORAL	250MG	No	No
002	NAPROXEN	NAPROXEN	TABLET;ORAL	375MG	No	No
003	NAPROXEN	NAPROXEN	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076494-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	2004-01-14
A076494-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	2004-01-14
A076494-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	2004-01-14

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 4 · 129 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	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`301d65b070ca…`

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 7 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN SODIUM	Proficient Rx LP	2acd8e24-449d-4f5c-9323-504013ff4bf5	2023-07-28	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	A-S Medication Solutions	21930f73-d3c2-4462-a487-74ed871b74b2	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	a5ea3a84-7acd-4f24-9f0f-9f871ce1b5f4	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
naproxen	NAPROXEN	Cipla USA Inc.	a9549a47-3fa4-4a2b-95ac-b00e43aedae7	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	d0670241-f1f9-4fdf-83d4-547e7b800811	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	Asclemed USA, Inc.	a4fcb411-c918-459b-adc6-06dfa8ed8a50	2022-10-12	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	aa4d159c-9cbe-4d29-9532-33a312f1ae05	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	96601d76-50ea-4dc0-b588-d174f8d8bb51	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	98efdeb8-ea38-456e-953f-ba589727f284	2021-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	9c963e77-6e05-47d0-a8d3-e581777377b9	2021-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	32693390-763b-46dd-b821-65a7bf3c6671	2021-04-26	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	fc3ee94a-adb7-411e-a662-2f2c6ddbabaf	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	3e4e5371-d796-47c7-95c1-d99e82a0b282	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	3e14f839-d1e4-44df-a457-29f005b3e62e	2020-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	Bryant Ranch Prepack	5d399bf3-db49-411a-91b9-b410d702a65a	2020-12-14	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Exelan Pharmaceuticals, Inc.	46dbdb95-a0d0-4410-8d64-b22763b12af7	2020-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Cipla USA Inc.	e06c2b43-9882-442e-8413-10d9a33aecb9	2019-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	TIME CAP LABORATORIES	4350a2d9-5228-460e-b7b1-27e8fa846787	2018-10-09	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	e2347581-90da-429a-b17c-cffd0039fb86	2017-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN

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
0143-1346	Naproxen	Naproxen	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1347	Naproxen	Naproxen	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1348	Naproxen	Naproxen	West-Ward Pharmaceuticals Corp	ANDA	Current
10544-061	Naproxen	Naproxen	Blenheim Pharmacal, Inc.	ANDA	Current
43353-677	Naproxen	Naproxen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current