Home Applications 074789 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 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 A074789-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-02-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074789-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-02-27 cb3db0bc1861…
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 13 · 258 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Sense Naproxen Sodium NAPROXEN SODIUM Preferred Pharmaceuticals Inc. 2183df53-ac90-4d43-8a5d-8421036bc4cb 2026-07-28 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Preferred Pharmaceuticals, Inc. 20eb9d9f-11df-464f-a1b0-949f8fda4042 2026-07-28 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM PD-Rx Pharmaceuticals, Inc. d2b1eedb-2be0-42af-ba0b-9da98560c91e 2026-07-24 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Back and Muscle Pain NAPROXEN SODIUM CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 4039504c-e612-4503-854a-62ee06780956 2026-07-13 Warnings Name fallback generic name: NAPROXEN SODIUM naproxen sodium NAPROXEN SODIUM H E B b5dcf3df-2628-49c7-9d96-64886bebe631 2026-07-13 Warnings Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) c28c4fd2-1428-421c-b62f-265e472d833e 2026-07-09 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM ScieGen Pharmaceuticals, Inc. 79f48c92-783d-40f2-9865-89958a9f9de6 2026-07-07 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Aleve Caplets NAPROXEN SODIUM Select Consumer Group 3ca84972-f8c9-1881-e063-6294a90a9070 2026-07-03 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Lidl US LLC 3d01220c-c5ec-4604-8cef-9ecb807ccd53 2026-06-22 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Rite Aid Corporation 134e5ec6-c42a-43b6-adf2-2d7546875ead 2026-06-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Headache Pain NAPROXEN SODIUM L.N.K. International, Inc. 6161b881-f422-47ae-86ba-a28d669bce79 2026-06-18 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Family Dollar Services Inc d9c63e1f-c2ad-434b-8a21-7fff21b7477b 2026-06-03 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM PD-Rx Pharmaceuticals, Inc. c5146d73-2f34-4dfe-ac29-97071279dc4d 2026-05-26 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Berkley and Jensen Naproxen Sodium NAPROXEN SODIUM BJWC 9530b649-3e01-452c-99a6-cff47fa4085b 2026-05-21 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM ST. MARY'S MEDICAL PARK PHARMACY 181c2d5b-2c61-bf20-e063-6294a90a3f7f 2026-05-20 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 2794b60d-d09b-4115-9ff2-07ff15524e78 2026-05-15 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Rite Aid Corporation e6277515-c606-4535-9c29-08cade045aee 2026-05-14 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM CVS Pharmacy c194124b-a5f6-423e-bc9a-7b611df990a8 2026-05-13 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM naproxen sodium NAPROXEN SODIUM Bionpharma Inc. 9343c79f-9994-4599-bcfe-0a93e49d726e 2026-05-12 Warnings Name fallback brand name: naproxen sodium generic name: NAPROXEN SODIUM Good Sense Naproxen Sodium NAPROXEN SODIUM L. Perrigo Company 8e150c00-8e5b-40b4-a964-cb70442c2752 2026-05-11 Warnings Name fallback generic name: NAPROXEN SODIUM