Application 074635

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXEN SODIUMNAPROXEN SODIUMTABLET;ORAL220MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074635-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL1997-01-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074635-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074635-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074635-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13cb3db0bc1861…

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 2 of 13 · 258 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline naproxen sodiumNAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFI89c02e55-fa08-4001-96fc-8a01e7e74d5a2026-05-06WarningsName fallback
generic name: NAPROXEN SODIUM
all day reliefNAPROXEN SODIUMPublix Super Markets Inc0f8843be-50a3-442c-9016-d9da3b444f602026-05-06WarningsName fallback
generic name: NAPROXEN SODIUM
rugby all day reliefNAPROXEN SODIUMRugby Laboratoriesf587a428-291c-4c54-80fe-244a961b05212026-05-06WarningsName fallback
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMAmazon.com Services LLC04a298dc-c525-8198-e063-6294a90a6f962026-04-27WarningsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsName fallback
generic name: NAPROXEN SODIUM
naproxen sodiumNAPROXEN SODIUMBionpharma Inc.ba4f927a-4bbe-0d87-e053-2995a90a8c202026-04-20WarningsName fallback
brand name: naproxen sodium
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackbee7b482-8ba5-411d-90ee-de00df50d2b72026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepacke9eb8c40-85d9-4c8e-9523-a21d3591260f2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackf6f4a670-235e-4235-84a8-a74dc8ca55862026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
AleveNAPROXEN SODIUMNavajo Manufacturing Company Inc.590f3be2-20df-4643-9114-e7ed4cf9155c2026-04-08WarningsName fallback
generic name: NAPROXEN SODIUM
Rapidol NaproxenNAPROXEN SODIUMPharmadel LLCc94c4b6e-a48b-cee5-e053-2995a90a49ac2026-03-20WarningsName fallback
generic name: NAPROXEN SODIUM
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.02941928-128a-2c88-e063-6294a90ac6ba2026-03-12WarningsName fallback
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMWalgreensd9806ad8-1cea-4599-97ef-a956ec7f0e212026-03-11WarningsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Naproxen Back and Muscle PainNAPROXEN SODIUML.N.K. International, Inc.68944663-0dc0-4d3a-a36b-019061bdbfa02026-03-09WarningsName fallback
generic name: NAPROXEN SODIUM
AnaDentNAPROXEN SODIUMBelmora LLC236674db-da4d-415c-a160-7086eaf5bff52026-03-03WarningsName fallback
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMCVS Pharmacyefe4352f-856b-4ada-8bd4-0a78423447dc2026-02-27WarningsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUML.N.K. International, Inc.717518e4-2537-4229-b765-c6acfe963d4b2026-02-25WarningsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Naproxen sodiumNAPROXEN SODIUMPHOENIX RX LLC47d18804-d8d6-8248-e063-6394a90a48a92026-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Naproxen sodium
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMBetter Living Brands, LLC3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c0412026-02-13WarningsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC369911ea-9069-9c45-e063-6394a90a5ce62026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Naproxen Sodium
generic name: NAPROXEN SODIUM