Home Applications 074635 Application 074635
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 A074635-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13
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 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074635-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074635-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074635-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 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 6 of 13 · 258 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CALMADOL PAIN RELIEVER NAPROXEN SODIUM GRANDALL DISTRIBUTING, LLC 8edec8d1-a323-436b-8329-c327438516e3 2025-10-28 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Family Dollar Services Inc b6205032-f5c6-494a-8b87-adbbbc3982e7 2025-10-27 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Amerisource Bergen 1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0 2025-10-20 Warnings Name fallback generic name: NAPROXEN SODIUM First Aid Direct All Day Pain Relief NAPROXEN SODIUM Cintas Corporation 1c9384c1-52f8-4482-88fc-5f5b6d770c42 2025-09-22 Warnings Name fallback generic name: NAPROXEN SODIUM foster and thrive all day pain relief NAPROXEN SODIUM Strategic Sourcing Services LLC 01746bb6-4068-4737-ba38-04cd5f1a81ba 2025-09-12 Warnings Name fallback generic name: NAPROXEN SODIUM Bayer Aleve NAPROXEN SODIUM Unifirst First Aid Corporation 5dd569ca-d03e-410c-af98-4732c823d595 2025-09-09 Warnings Name fallback generic name: NAPROXEN SODIUM Medique at Home Mediproxen NAPROXEN SODIUM Unifirst First Aid Corporation b591ba4f-d7d3-4c81-e053-2995a90a7c6e 2025-09-09 Warnings Name fallback generic name: NAPROXEN SODIUM Medique Mediproxen NAPROXEN SODIUM Unifirst First Aid Corporation f6261d45-df1f-483b-b013-3cd6f78d9d43 2025-09-08 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Aurobindo Pharma Limited 37b264f9-b46d-4635-8fab-246b1e08b653 2025-09-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Amerisource Bergen 4023f2a0-896b-45f9-9f62-6c12d318ec66 2025-09-02 Warnings Name fallback generic name: NAPROXEN SODIUM Good Sense Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack e5e8768d-c6e0-4018-b788-5ce86929f7b0 2025-08-26 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium PM NAPROXEN SODIUM Strategic Sourcing Services LLC 7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba 2025-08-20 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium PM NAPROXEN SODIUM Strategic Sourcing Services LLC 03a331d8-c957-4949-894f-51d9bd15e0d0 2025-08-20 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM P & L Development, LLC fc65fe79-c93b-4247-b9af-e562792a3e64 2025-08-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM Safeway 396f4e60-3dde-433f-b4b5-25f351c96d57 2025-08-19 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Preferred Pharmaceuticals, Inc. 6ae413ba-5a48-423f-8b8d-7a42661cf836 2025-08-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM L.N.K. International, Inc. 82412133-c11a-4905-a119-965f44de10b7 2025-08-18 Warnings Name fallback generic name: NAPROXEN SODIUM Dr Simi All Day Pain Relief NAPROXEN SODIUM Farmacias De Similares TX LLC 3c6d4bb5-eb6f-944b-e063-6294a90ae8de 2025-08-15 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM 220MG CVS Pharmacy, Inc. 1fde52e7-7a7f-40e8-e063-6394a90a922a 2025-08-11 Warnings Name fallback brand name: Naproxen Sodium Aleve Headache Pain NAPROXEN SODIUM Bayer HealthCare LLC. 3ba28e47-1294-bec7-e063-6294a90ac80a 2025-08-05 Warnings Name fallback generic name: NAPROXEN SODIUM