Application 074182

Type: ANDA
Sponsor: PLIVA

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
A074182-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	1996-06-27
A074182-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	1996-06-27
A074182-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	1996-06-27

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	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074182-002	NAPROXEN	375MG	TABLET / ORAL	1996-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074182-003	NAPROXEN	500MG	TABLET / ORAL	1996-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074182-001	NAPROXEN	250MG	TABLET / ORAL	1996-06-27	`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 3 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	fa2fe6fd-c476-dd29-e053-6294a90a9e9e	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	0de6d673-fa76-e9c0-e063-6394a90a9ded	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	Northwind Health Company, LLC	f32d755e-4984-ee40-e053-2995a90a4ebe	2026-01-01	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	fb07a76b-98ce-85dd-e053-6294a90aa6a8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	ab6ec2c9-5df9-346c-e053-2a95a90ac81d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	db478961-d984-7c8e-e053-2995a90a8a12	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Northwind Health Company, LLC	c986ba9a-6f48-8347-e053-2a95a90aa1c1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	QPharma, Inc.	307aa67f-53b9-4c60-a328-091bbf6338d4	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Safeway, Inc	f2a273f8-d623-dc2f-e053-2995a90a0c02	2025-12-19	Warnings	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Sunrise Pharmaceutical, Inc.	f2fb222a-b854-4e6f-9027-2e08aed24185	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Granules Pharmaceuticals Inc.	c1cb9bb9-fbae-5e5c-e053-2995a90a0d21	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	QPharma Inc	c0a4839b-7154-c82c-e053-2a95a90a7e6d	2025-12-03	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	Granules India Ltd	1f8da545-bcfe-4c22-a9f1-d34108120aa0	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	PHOENIX RX LLC	43912294-77c9-eda8-e063-6394a90adf0a	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	8c3398bd-66b1-4a14-8aaa-e4a2d6749a08	2025-11-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	Better Living Brands, LLC	43745d42-f859-4168-a2dd-2c8ae47ae590	2025-10-28	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	Medcore LLC	129392c8-8ce1-4b78-8863-042db880095f	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	b6205032-f5c6-494a-8b87-adbbbc3982e7	2025-10-27	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN SODIUM	Amerisource Bergen	1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0	2025-10-20	Warnings	Name fallback brand name: Naproxen

Reported adverse events (FAERS/openFDA)#

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