Application 074789

Type: ANDA
Sponsor: CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	220MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074789-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1997-02-27

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 2 · 43 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	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074789-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074789-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074789-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-02-27	`f41ea6bd6efb…`

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 11 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Basic Care Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	4bc62f12-15a5-40bd-bf99-ec15de0914c7	2024-02-15	Warnings	Name fallback generic name: NAPROXEN SODIUM
Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	2d04fef4-6a26-4df2-af90-816107e7dfe2	2024-02-02	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Relief	NAPROXEN SODIUM	Publix Supermarkets, Inc.	4db86c5b-62bb-4638-9f1e-98dc2680d6cc	2024-01-23	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever	NAPROXEN SODIUM	Amneal Pharmaceuticals of New York LLC	0bb41b8c-6031-4e96-95e1-31adab811837	2023-12-31	Warnings	Name fallback generic name: NAPROXEN SODIUM
PROXEN NP 660	NAPROXEN SODIUM	OPMX LLC	09990b2f-202e-b4df-e063-6394a90a055b	2023-12-27	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Bionpharma Inc.	3e10256f-0a5f-49e4-9518-a72b10490f89	2023-12-27	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
All Day Pain Relief	NAPROXEN SODIUM	H E B	6dd54a14-67cd-4295-9bd5-1d6f8cb9316d	2023-12-19	Warnings	Name fallback generic name: NAPROXEN SODIUM
All Day Back and Muscle Pain Relief	NAPROXEN SODIUM	Walmart Inc.	062b9ffe-b4fc-9f5a-e063-6294a90a560e	2023-12-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Asclemed USA, Inc.	b0571e62-9330-438d-a2ba-873477f52dc4	2023-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	fed305f1-e32d-e1ff-e053-6294a90a273d	2023-10-03	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Strategic Sourcing Services LLC	435e55b2-3d75-4a1e-9f00-69b29baf37af	2023-10-02	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	TIME CAP LABORATORIES, INC	ab7b7b8e-923b-4dc1-812c-78e85de1bee1	2023-09-13	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
naproxen sodium	NAPROXEN SODIUM	CVS Pharmacy	f246ff56-23e4-4d39-9d73-7c0dd2b99fd3	2023-08-22	Warnings	Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM
Naproxen	NAPROXEN SODIUM	Proficient Rx LP	2acd8e24-449d-4f5c-9323-504013ff4bf5	2023-07-28	Warnings	Name fallback generic name: NAPROXEN SODIUM
Pain Relief	NAPROXEN SODIUM	BETTER LIVING BRANDS, LLC	eb604ea6-f5c1-156b-e053-2a95a90a76d7	2023-06-13	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	BETTER LIVING BRANDS LLC.	f2c06861-0322-93ed-e053-2995a90a5902	2023-06-13	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM, COATED TABLETS	MARKSANS PHARMA LIMITED	48cb1363-ff12-40ee-a87a-2252dfbf8ff7	2023-06-09	Warnings	Name fallback brand name: Naproxen Sodium
all day pain relief	NAPROXEN SODIUM	Walgreen Company	8ea540bf-4958-41f9-980f-5936c074a51d	2023-05-08	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	A-S Medication Solutions	2523a4de-1af9-46f4-93dc-e8b4029d69c4	2023-04-27	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Bayer Aleve	NAPROXEN SODIUM	Acme United Corporation	f758201c-28b8-5357-e053-6394a90a1e5d	2023-03-20	Warnings	Name fallback generic name: NAPROXEN SODIUM

Reported adverse events (FAERS/openFDA)#

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