Application 074661

Type
ANDA
Sponsor
PERRIGO

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074661-001NAPROXEN 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1384e616aacf4f…
2026-08-18 06:07:402026-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074661-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074661-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13f41ea6bd6efb…

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Naproxen SodiumNAPROXEN SODIUMPreferred Pharmaceuticals Inc.2183df53-ac90-4d43-8a5d-8421036bc4cb2026-07-28WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.d2b1eedb-2be0-42af-ba0b-9da98560c91e2026-07-24WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
naproxen sodiumNAPROXEN SODIUMH E Bb5dcf3df-2628-49c7-9d96-64886bebe6312026-07-13WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 37808-713
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.c5146d73-2f34-4dfe-ac29-97071279dc4d2026-05-26WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Berkley and Jensen Naproxen SodiumNAPROXEN SODIUMBJWC9530b649-3e01-452c-99a6-cff47fa4085b2026-05-21WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company8e150c00-8e5b-40b4-a964-cb70442c27522026-05-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
equaline naproxen sodiumNAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFI89c02e55-fa08-4001-96fc-8a01e7e74d5a2026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 41163-707
all day reliefNAPROXEN SODIUMPublix Super Markets Inc0f8843be-50a3-442c-9016-d9da3b444f602026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
rugby all day reliefNAPROXEN SODIUMRugby Laboratoriesf587a428-291c-4c54-80fe-244a961b05212026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMCVS Pharmacyefe4352f-856b-4ada-8bd4-0a78423447dc2026-02-27WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Topcare All Day Pain ReliefNAPROXEN SODIUMTopco Associates LLC7f1cda40-9a67-4de1-af56-ab881c6354c42026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 36800-490
naproxen sodiumNAPROXEN SODIUMH E B2f9439bb-e808-4c54-ba61-f75f117c8b372026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 37808-652
Naproxen SodiumNAPROXEN SODIUMPadagis Israel Pharmaceuticals Ltdcdb60f74-ce23-4015-90eb-b23a2275f6cb2026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
topcare back and muscle painNAPROXEN SODIUMTopco Associates LLCde587e8f-38f2-4e7a-8e6a-64e48f280c4f2026-02-07WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 36800-696
Naproxen SodiumNAPROXEN SODIUMMeijer Distribution Incdb87d1da-8507-4bbf-aefc-3dbd48cde26b2026-02-05WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 41250-680
Rugby All Day ReliefNAPROXEN SODIUMBryant Ranch Prepack3238dfdc-82d1-4afb-b27c-0ba0a5d247442026-02-04WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company6bc74cda-458c-480e-a33c-d2ba68d5e6bd2026-01-29WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Care One Naproxen SodiumNAPROXEN SODIUMAmerican Sales Companybc5ddcf2-640c-4683-a60f-ca1c8b4188732026-01-29WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 41520-533
Leader All Day Pain ReliefNAPROXEN SODIUMCardinal Health 110, LLC. dba Leaderdbf007f5-c792-43a7-8cc1-bfa617f3a7fa2026-01-26WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
naproxen sodiumNAPROXEN SODIUMMeijer Distribution Incf4e57560-ae89-4fc3-a66b-ebf3dc3f24482026-01-22WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
ndc (product): 41250-818

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 5 · 328 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30142-500Naproxen SodiumNaproxen SodiumKroger CompanyANDACurrent
30142-500Naproxen SodiumNaproxen SodiumKroger CompanyANDACurrent
30142-617naproxen sodiumNaproxen SodiumKroger CompanyANDACurrent
30142-617naproxen sodiumNaproxen SodiumKroger CompanyANDACurrent
30142-617naproxen sodiumNaproxen SodiumKroger CompanyANDACurrent
30142-617naproxen sodiumNaproxen SodiumKroger CompanyANDACurrent
33261-079good sense all day pain reliefNaproxen SodiumAidarex Pharmaceuticals LLCANDACurrent
36800-140Topcare All Day Pain ReliefNaproxen sodiumTopco Associates LLCANDACurrent
36800-140Topcare All Day Pain ReliefNaproxen sodiumTopco Associates LLCANDACurrent
36800-140Topcare All Day Pain ReliefNaproxen sodiumTopco Associates LLCANDACurrent
36800-368TopCare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-368TopCare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-368TopCare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-368TopCare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-368TopCare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-368TopCare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-490Topcare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-490Topcare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-490Topcare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-490Topcare All Day Pain ReliefNaproxen SodiumTopco Associates LLCANDACurrent
36800-696topcare back and muscle painnaproxen sodiumTopco Associates LLCANDACurrent
36800-696topcare back and muscle painnaproxen sodiumTopco Associates LLCANDACurrent
37012-368naproxen sodiumNaproxen SodiumShopko Stores Operating Co., LLCANDACurrent
37012-368naproxen sodiumNaproxen SodiumShopko Stores Operating Co., LLCANDACurrent
37808-259All Day Pain ReliefNaproxen SodiumH E BANDACurrent
37808-339all day pain reliefNaproxen sodiumH E BANDACurrent
37808-500All Day Pain ReliefNaproxen SodiumH E BANDACurrent
37808-631naproxen sodiumNaproxen sodiumH E BANDACurrent
37808-631naproxen sodiumNaproxen sodiumH E BANDACurrent
37808-631naproxen sodiumNaproxen sodiumH E BANDACurrent
37808-631naproxen sodiumNaproxen sodiumH E BANDACurrent
37808-652naproxen sodiumNaproxen SodiumH E BANDACurrent
37808-652naproxen sodiumNaproxen SodiumH E BANDACurrent
37808-652naproxen sodiumNaproxen SodiumH E BANDACurrent
37808-713naproxen sodiumNaproxen SodiumH E BANDACurrent
37808-713naproxen sodiumNaproxen SodiumH E BANDACurrent
37808-713naproxen sodiumNaproxen SodiumH E BANDACurrent
41163-323equaline naproxen sodiumNaproxen sodiumSupervalu IncANDACurrent
41163-511equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-511equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-511equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-511equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-707equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-707equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-707equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41163-707equaline naproxen sodiumNaproxen SodiumSupervalu IncANDACurrent
41190-368ShopRite Naproxen SodiumNaproxen SodiumWakefern Food CorporationANDACurrent
41190-368ShopRite Naproxen SodiumNaproxen SodiumWakefern Food CorporationANDACurrent
41250-313naproxen sodiumNaproxen sodiumMeijer Distribution IncANDACurrent
41250-313naproxen sodiumNaproxen sodiumMeijer Distribution IncANDACurrent
41250-313naproxen sodiumNaproxen sodiumMeijer Distribution IncANDACurrent
41250-477Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-477Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-477Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-477Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-611Naproxen SodiumNaproxen SodiumMeijer, Inc.ANDACurrent
41250-611Naproxen SodiumNaproxen SodiumMeijer, Inc.ANDACurrent
41250-680Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-680Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-680Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-680Naproxen SodiumNaproxen SodiumMeijer Distribution IncANDACurrent
41250-818naproxen sodiumnaproxen sodiumMeijer Distribution IncANDACurrent
41250-818naproxen sodiumnaproxen sodiumMeijer Distribution IncANDACurrent
41250-818naproxen sodiumnaproxen sodiumMeijer Distribution IncANDACurrent
41520-349Care One Naproxen SodiumNaproxen sodiumAmerican Sales CompanyANDACurrent
41520-349Care One Naproxen SodiumNaproxen sodiumAmerican Sales CompanyANDACurrent
41520-349Care One Naproxen SodiumNaproxen sodiumAmerican Sales CompanyANDACurrent
41520-507CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-507CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-507CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-507CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-507CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-533Care One Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-533Care One Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-533Care One Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-702CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
41520-702CareOne Naproxen SodiumNaproxen SodiumAmerican Sales CompanyANDACurrent
42254-230all day pain reliefNaproxen SodiumRebel Distributors CorpANDACurrent
42507-140all day reliefNaproxen sodiumHyVee IncANDACurrent
42507-368all day reliefNaproxen SodiumHyVee IncANDACurrent