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 9 of 13 · 258 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join rugby all day relief NAPROXEN SODIUM A-S Medication Solutions 369f5123-283d-4aa6-8861-8d183f2ba94d 2025-03-18 Warnings Name fallback generic name: NAPROXEN SODIUM Care One Naproxen Sodium NAPROXEN SODIUM American Sales Company 88812af7-89ca-449b-9513-20c284543d0e 2025-03-13 Warnings Name fallback generic name: NAPROXEN SODIUM CareOne Naproxen Sodium NAPROXEN SODIUM American Sales Company 0ac4c343-a5b6-4f69-a75a-87074dc867e8 2025-03-04 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Meijer Distribution Inc 9551e84b-19bc-43e7-9c6e-0f24fdeb5abe 2025-03-03 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Bi-Mart 6d5cecc9-5095-477b-bfc7-45b6e7e689f0 2025-03-01 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Geri-Care Pharmaceutical Corp 9a61d544-e46d-6703-e053-2a95a90a32fd 2025-02-27 Warnings Name fallback generic name: NAPROXEN SODIUM All Day Relief NAPROXEN SODIUM Publix Super Markets Inc 688451a2-e94a-434a-8e9c-9fe3abf5c3d5 2025-02-06 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM NuCare Pharmaceuticals,Inc. f1ed8384-83d6-6f2a-e053-2a95a90ab08f 2025-02-04 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen NAPROXEN SODIUM Bryant Ranch Prepack f9ddc614-26b7-48dc-ae93-02da6388f2d5 2025-01-30 Warnings Name fallback generic name: NAPROXEN SODIUM DG Health Naproxen Sodium NAPROXEN SODIUM Dolgencorp Inc 534eaf8a-0d2a-4390-af92-af5c98ba56a5 2025-01-23 Warnings Name fallback generic name: NAPROXEN SODIUM dg health naproxen sodium NAPROXEN SODIUM Dolgencorp Inc 51e49a00-e040-4e7b-838c-c77ed75a7f92 2025-01-22 Warnings Name fallback generic name: NAPROXEN SODIUM Basic Care Naproxen Sodium NAPROXEN SODIUM Amazon.com Services LLC d5c185d9-0bea-4970-b1e7-201a51106ad6 2025-01-22 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Direct Rx d95279d9-6e2a-0bd6-e053-2a95a90a447d 2025-01-21 Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM dg health naproxen sodium NAPROXEN SODIUM Dolgencorp Inc 3ca9ce63-39f4-4ba9-b464-d048fd8e67c0 2025-01-15 Warnings Name fallback generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM Walgreen Company 318d4e2a-7108-4e88-8e56-5bec17ca4a3e 2025-01-11 Warnings Name fallback generic name: NAPROXEN SODIUM Aleve NAPROXEN SODIUM Lil' Drug Store Products, Inc abfcf13e-6eba-49e2-8ebf-459348714270 2025-01-06 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM NuCare Pharmaceuticals,Inc. b8e417d2-3fc8-9a5e-e053-2a95a90a4155 2025-01-03 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC a690dc39-95f2-4853-a291-05d7dc9a1551 2024-12-30 Warnings Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Teva Pharmaceuticals, Inc. 826fd9e3-22fe-408b-820c-f2b710189555 2024-12-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM DG Health Naproxen Sodium NAPROXEN SODIUM Dolgencorp Inc 43926764-f8d1-42b4-b55b-0524d9ff98f3 2024-12-27 Warnings Name fallback generic name: NAPROXEN SODIUM