Application 204872

Type: ANDA
Sponsor: LNK INTL INC

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 44.

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
A204872-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2017-01-23

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3a93d1ddd44b…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Direct All Day Pain Relief	NAPROXEN SODIUM	Cintas Corporation	1c9384c1-52f8-4482-88fc-5f5b6d770c42	2025-09-22	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Geri-Care Pharmaceutical Corp	9a61d544-e46d-6703-e053-2a95a90a32fd	2025-02-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 57896-954
Naproxen	NAPROXEN SODIUM	Bryant Ranch Prepack	f9ddc614-26b7-48dc-ae93-02da6388f2d5	2025-01-30	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 71335-1282
Naproxen	NAPROXEN SODIUM	Proficient Rx LP	2acd8e24-449d-4f5c-9323-504013ff4bf5	2023-07-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 71205-595

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 2 of 2 · 121 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55319-604	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-604	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-604	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-604	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-604	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-714	All Day Pain Relief Back and Muscle Pain	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-714	All Day Pain Relief Back and Muscle Pain	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-714	All Day Pain Relief Back and Muscle Pain	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-714	All Day Pain Relief Back and Muscle Pain	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
57896-954	Naproxen	Naproxen Sodium	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-954	Naproxen	Naproxen Sodium	Geri-Care Pharmaceutical Corp	ANDA	Current
68016-676	Naproxen Sodium	Naproxen Sodium	Chain Drug Consortium	ANDA	Current
68016-676	Naproxen Sodium	Naproxen Sodium	Chain Drug Consortium	ANDA	Current
68016-676	Naproxen Sodium	Naproxen Sodium	Chain Drug Consortium	ANDA	Current
68016-676	Naproxen Sodium	Naproxen Sodium	Chain Drug Consortium	ANDA	Current
68016-676	Naproxen Sodium	Naproxen Sodium	Chain Drug Consortium	ANDA	Current
68071-5039	Naproxen	Naproxen Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7572	Naproxen	Naproxen Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7572	Naproxen	Naproxen Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7572	Naproxen	Naproxen Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7572	Naproxen	Naproxen Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
69842-417	Naproxen Sodium	Naproxen Sodium	CVS PHARMACY	ANDA	Current
69842-417	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-417	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-417	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-417	Naproxen Sodium	Naproxen Sodium	CVS Pharmacy	ANDA	Current
69842-417	Naproxen Sodium	Naproxen Sodium	CVS PHARMACY	ANDA	Current
70729-003	Naproxen Sodium Caplets	Naproxen sodium	Breeden Brothers, LLC	ANDA	Current
71205-595	Naproxen	Naproxen Sodium	Proficient Rx LP	ANDA	Current
71335-1282	Naproxen	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
72189-272	Naproxen Sodium	Naproxen Sodium	DirectRx	ANDA	Current
72189-272	Naproxen Sodium	Naproxen Sodium	DirectRx	ANDA	Current
72189-272	Naproxen Sodium	Naproxen Sodium	DirectRx	ANDA	Current
79903-005	All Day Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-005	All Day Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-005	All Day Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-005	All Day Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-005	All Day Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-005	All Day Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-098	All Day Back and Muscle Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current
79903-098	All Day Back and Muscle Pain Relief	Naproxen Sodium	WALMART INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46983	ORIG	2017-01-27