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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`e64feba35796…`

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 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Artridol	NAPROXEN SODIUM	Zapotol Products Corp	c422d300-3f4e-4121-8eaf-56683911b884	2026-08-05	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	20eb9d9f-11df-464f-a1b0-949f8fda4042	2026-07-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Back and Muscle Pain	NAPROXEN SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4039504c-e612-4503-854a-62ee06780956	2026-07-13	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 51316-817
Naproxen Sodium	NAPROXEN SODIUM	Lidl US LLC	3d01220c-c5ec-4604-8cef-9ecb807ccd53	2026-06-22	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	134e5ec6-c42a-43b6-adf2-2d7546875ead	2026-06-19	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 11822-4171
Naproxen Headache Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	6161b881-f422-47ae-86ba-a28d669bce79	2026-06-18	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 50844-471
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	d9c63e1f-c2ad-434b-8a21-7fff21b7477b	2026-06-03	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	e6277515-c606-4535-9c29-08cade045aee	2026-05-14	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 11822-6040
Naproxen Back and Muscle Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	68944663-0dc0-4d3a-a36b-019061bdbfa0	2026-03-09	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 50844-714
AnaDent	NAPROXEN SODIUM	Belmora LLC	236674db-da4d-415c-a160-7086eaf5bff5	2026-03-03	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 27854-170
Naproxen Sodium	NAPROXEN SODIUM	L.N.K. International, Inc.	717518e4-2537-4229-b765-c6acfe963d4b	2026-02-25	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 50844-604 ndc (product): 50844-417
Naproxen Sodium	NAPROXEN SODIUM	Better Living Brands, LLC	3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041	2026-02-13	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Back and Muscle Pain	NAPROXEN SODIUM	Rite Aid Corporation	e162bd50-f94a-4c76-8f1b-62114f283809	2026-02-11	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 11822-4170
Flanax Menstrual Pain Reliever	NAPROXEN SODIUM	Belmora LLC	2b4135b3-389c-46e2-ae86-7674c2ab9a32	2026-01-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 27854-165
Flanax	NAPROXEN SODIUM	Belmora LLC	2c099d45-f03a-4161-a6af-8fe5965f2748	2026-01-06	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 27854-160
All Day Pain Relief	NAPROXEN SODIUM	WALMART INC.	c4909e43-57ba-44bc-a234-a02cc884891c	2025-12-11	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
24/7 Life by 7-Eleven Naproxen Sodium	NAPROXEN SODIUM TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44716954-006a-4c56-e063-6294a90a0f14	2025-11-25	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Athlete's Needs Inc	d5984c9d-3941-45d6-8392-87564b2faae0	2025-11-15	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 53185-604
Naproxen	NAPROXEN SODIUM	Better Living Brands, LLC	43745d42-f859-4168-a2dd-2c8ae47ae590	2025-10-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	b6205032-f5c6-494a-8b87-adbbbc3982e7	2025-10-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 121 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11822-4170	Back and Muscle Pain	Naproxen Sodium	Rite Aid Corporation	ANDA	Current
11822-4170	Back and Muscle Pain	Naproxen Sodium	Rite Aid Corporation	ANDA	Current
11822-4171	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	ANDA	Current
11822-6040	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	ANDA	Current
11822-6040	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	ANDA	Current
27854-160	Flanax	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-160	Flanax	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-160	Flanax	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-160	Flanax	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-160	Flanax	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-160	Flanax	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Flanax Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Flanax Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-165	Menstrual Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-170	AnaDent	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-170	AnaDent	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-170	AnaDent	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-170	AnaDent	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-170	AnaDent	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-170	AnaDent	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-180	Ana-Dent Toothache Relief	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-180	Ana-Dent Toothache Relief	Naproxen Sodium	Belmora LLC	ANDA	Current
46122-562	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-562	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-562	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-562	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-562	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
46122-564	Naproxen	Naproxen Sodium	Amerisource Bergen	ANDA	Current
49035-903	Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-903	Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-903	Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
49035-903	Naproxen Sodium	Naproxen Sodium	Wal-Mart Stores Inc	ANDA	Current
50844-261	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-261	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-261	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-261	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-261	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-261	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-417	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-417	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-417	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-417	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-417	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-471	Naproxen Headache Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-471	Naproxen Headache Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-471	Naproxen Headache Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-604	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-604	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-604	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-604	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-604	Naproxen Sodium	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-714	Naproxen Back and Muscle Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-714	Naproxen Back and Muscle Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-714	Naproxen Back and Muscle Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-714	Naproxen Back and Muscle Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-714	Naproxen Back and Muscle Pain	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
51316-417	Naproxen Sodium	Naproxen Sodium	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ANDA	Current
51316-417	Naproxen Sodium	Naproxen Sodium	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ANDA	Current
51316-714	Headache Pain	Naproxen Sodium	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ANDA	Current
51316-817	Back and Muscle Pain	Naproxen Sodium	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ANDA	Current
51316-817	Back and Muscle Pain	Naproxen Sodium	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ANDA	Current
53185-604	Naproxen Sodium	Naproxen Sodium	Athlete's Needs Inc	ANDA	Current
53185-604	Naproxen Sodium	Naproxen Sodium	Athlete's Needs Inc	ANDA	Current
53185-604	Naproxen Sodium	Naproxen Sodium	Athlete's Needs Inc	ANDA	Current
55319-417	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-417	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-417	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-417	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current
55319-417	All Day Pain Relief	Naproxen Sodium	Family Dollar Services Inc	ANDA	Current

Documents#

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