Home Applications 204872 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 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 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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-10-28 04:53 UTC 2022-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 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 1 of 2 · 27 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN SODIUM L.N.K. International, Inc. 82412133-c11a-4905-a119-965f44de10b7 2026-08-17 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 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 ndc (product): 68788-7572 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 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 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 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 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 AnaDent NAPROXEN SODIUM Belmora LLC 236674db-da4d-415c-a160-7086eaf5bff5 2026-03-03 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 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 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 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 Flanax NAPROXEN SODIUM Belmora LLC 2c099d45-f03a-4161-a6af-8fe5965f2748 2026-01-06 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 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 ndc (product): 79903-005 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 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
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