Application 074242

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	EQ 250MG BASE	No	No
002	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	EQ 500MG 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
A074242-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL			1996-06-20
A074242-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL			1996-06-20

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	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074242-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	1996-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074242-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	1996-06-20	`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 13 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	TIME CAP LABORATORIES, INC	17ecaee0-c1c6-4360-81c1-d6afe50b9b27	2021-12-01	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	Kroger Company	bc185bf2-bc2c-f439-e053-2995a90a93d0	2021-06-03	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	397db794-027c-4a89-993e-07c208b457a3	2020-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Flanax Pain Reliever/Fever reducer	NAPROXEN SODIUM	Belmora LLC	05337e0b-8baf-42d6-a642-3052f77ed304	2020-05-29	Warnings	Name fallback generic name: NAPROXEN SODIUM
Ana-Dent PAIN RELIEF	NAPROXEN SODIUM	Belmora LLC	04721306-2850-4e0a-9dd9-7cabb575f3c7	2020-05-18	Warnings	Name fallback generic name: NAPROXEN SODIUM
Flanax Pain Reliever/Fever Reducer	NAPROXEN SODIUM	Belmora LLC	a93e4966-9dd3-40ba-b7d6-6ca8fef229c6	2020-05-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	PuraCap Pharmaceutical LLC	fc865e81-164c-48e9-8fb9-6fc27d1c33cf	2019-12-10	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	1d5981dd-e3f5-48a3-a5f1-ce49689cdfac	2019-11-08	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	c0dc7f87-355c-4357-b99d-f03693d350a7	2019-11-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	SA3, LLC	313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	2019-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	SUPERVALU INC	1aedc0a1-466a-40c6-bb4c-53b7e8f83aff	2018-12-17	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Premier Value Alliance LLC	803b1569-46f0-4937-842c-0c363fe0ed79	2018-10-30	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.