Application 074198

Type: ANDA
Sponsor: TEVA

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
A074198-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL			1993-12-21
A074198-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL			1993-12-21

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		1993-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		1993-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074198-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	1993-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074198-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	1993-12-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074198-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074198-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074198-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074198-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074198-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074198-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074198-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074198-002	AB	1	`ea99ee380514…`

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 12 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	HEB	df8ea301-c48b-4da4-9e8e-5c69cac6cba7	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	TOP CARE (Topco Associates LLC)	c62b7fa0-5ae9-276c-e053-2995a90ade25	2022-12-29	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION INC.	c482db41-b115-c24f-e053-2a95a90a2947	2022-12-21	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	Camber Consumer Care Inc	d1008e19-ff0d-4ed2-909d-bae5a82a1234	2022-11-23	Warnings	Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Care One (American Sales Company)	043f7032-4e83-4642-93a8-6c09de26b43f	2022-11-21	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de03311d-fb58-43f5-a110-aac9a39c9132	2022-11-07	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	a90bfc07-d01e-427c-b2df-41bff7612d2f	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	e668c80f-dd53-4b82-8678-5e4fccb13023	2022-05-02	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
betr headache pain relief	NAPROXEN SODIUM	Live Betr LLC	eaf6d2fc-ebcb-4d11-8e3f-a494f0f7920b	2022-04-01	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	a380cace-43dc-4b9c-84d3-0b38241d9d2e	2022-03-30	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	462a7e41-b899-4e08-8113-b48ece0ad8d8	2022-03-17	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	DISCOUNT DRUG MART, INC.	b00c0e86-4c0b-45bf-948f-824ea0f09e39	2022-03-16	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.