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 4 of 13 · 258 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Flanax NAPROXEN SODIUM Belmora LLC 2c099d45-f03a-4161-a6af-8fe5965f2748 2026-01-06 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM PD-Rx Pharmaceuticals, Inc. 145cdcc0-9bd5-4a0e-81fc-11a24d181980 2026-01-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Safeway, Inc. deb1be0f-64ae-46b5-b54a-1a58eec6492e 2026-01-05 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Glenmark Pharmaceuticals Inc., USA 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 2025-12-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Granules USA, Inc. 8cb8030c-b281-315c-e053-2a95a90a36f0 2025-12-22 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Safeway, Inc f2a297c2-3898-5e47-e053-2995a90ab3cc 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM TARGET CORPORATION fdb87abd-3176-dd62-e053-6394a90a6fcc 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM CVS 1042b202-e8ee-1839-e063-6294a90ac90b 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM CVS 10429d07-de96-5542-e063-6294a90a7371 2025-12-19 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM signature care naproxen sodium NAPROXEN SODIUM Safeway 85f78e63-98aa-4cf3-887d-0ac535184f97 2025-12-16 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM MEIJER DISTRIBUTION INC 89f82399-9f71-49dd-8710-b60f346c576c 2025-12-12 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM VALU MERCHANDISERS COMPANY 12748345-0d79-d6f8-e063-6394a90ab6c6 2025-12-11 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM VALU MERCHANDISERS COMPANY 1274889d-803c-d7fd-e063-6394a90ab9a8 2025-12-11 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM All Day Pain Relief NAPROXEN SODIUM WALMART INC. c4909e43-57ba-44bc-a234-a02cc884891c 2025-12-11 Warnings Name fallback generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association d9e72c3f-addc-4391-a7a4-2680a3e7f5c4 2025-12-10 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Chain Drug Marketing Association 2ee83008-c012-48d6-9479-65e7d6f50f4c 2025-12-10 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM Harris Teeter 27938b08-ff37-4587-aa81-5ec3ef21a28a 2025-12-09 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Naproxen Sodium NAPROXEN SODIUM TARGET Corporation 36bf8594-9303-c816-e063-6294a90af705 2025-12-08 Warnings Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM Aleve Headache Pain NAPROXEN SODIUM Bayer HealthCare LLC c69f4926-c5cd-63a0-e053-2a95a90a2ca6 2025-12-04 Warnings Name fallback generic name: NAPROXEN SODIUM Aleve NAPROXEN SODIUM Bayer HealthCare LLC. 00ef5b30-71d0-4cb4-84a3-48c67d1cea2a 2025-12-04 Name fallback generic name: NAPROXEN SODIUM