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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13e64feba35796…

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
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
ndc (product): 0113-4368
equaline naproxen sodiumNAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFI89c02e55-fa08-4001-96fc-8a01e7e74d5a2026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
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
ndc (product): 0536-1094
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
naproxen sodiumNAPROXEN SODIUMH E B2f9439bb-e808-4c54-ba61-f75f117c8b372026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
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
Naproxen SodiumNAPROXEN SODIUMMeijer Distribution Incdb87d1da-8507-4bbf-aefc-3dbd48cde26b2026-02-05WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
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
ndc (product): 0113-0901
Care One Naproxen SodiumNAPROXEN SODIUMAmerican Sales Companybc5ddcf2-640c-4683-a60f-ca1c8b4188732026-01-29WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
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 Listings For This Application#

NDC listings for this application page 1 of 5 · 328 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0901Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-0901Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-0901Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-0901Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-1412good sense naproxen sodiumnaproxen sodiumL. Perrigo CompanyANDACurrent
0113-1773good sense naproxen sodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-4368Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-4368Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-4368Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-4368Good Sense Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-7033basic care naproxen sodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-7033basic care naproxen sodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-7368Basic Care Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-7368Basic Care Naproxen SodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-7901basic care naproxen sodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0113-7901basic care naproxen sodiumNaproxen SodiumL. Perrigo CompanyANDACurrent
0363-0140pain reliefNaproxen sodiumWalgreen CompanyANDACurrent
0363-0140pain reliefNaproxen sodiumWalgreen CompanyANDACurrent
0363-0140pain reliefNaproxen sodiumWalgreen CompanyANDACurrent
0363-0140pain reliefNaproxen sodiumWalgreen CompanyANDACurrent
0363-0368All Day Pain ReliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0368All Day Pain ReliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0368All Day Pain ReliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0368All Day Pain ReliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0490Pain ReliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0490Pain ReliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0938all day pain reliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0938all day pain reliefNaproxen SodiumWalgreen CompanyANDACurrent
0363-0938all day pain reliefNaproxen SodiumWalgreen CompanyANDACurrent
0536-1093Rugby All Day ReliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1093Rugby All Day ReliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1093Rugby All Day ReliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1093Rugby All Day ReliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1094rugby all day reliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1094rugby all day reliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1094rugby all day reliefNaproxen SodiumRugby LaboratoriesANDACurrent
0536-1094rugby all day reliefNaproxen SodiumRugby LaboratoriesANDACurrent
10202-4907 Select Naproxen SodiumNaproxen Sodium7-ElevenANDACurrent
10202-4907 Select Naproxen SodiumNaproxen Sodium7-ElevenANDACurrent
11673-368up and up naproxen sodiumNaproxen SodiumTarget CorporationANDACurrent
11673-368up and up naproxen sodiumNaproxen SodiumTarget CorporationANDACurrent
11673-368up and up naproxen sodiumNaproxen SodiumTarget CorporationANDACurrent
11673-368up and up naproxen sodiumNaproxen SodiumTarget CorporationANDACurrent
11673-909up and up naproxen sodiumnaproxen sodiumTarget CorporationANDACurrent
11673-909up and up naproxen sodiumnaproxen sodiumTarget CorporationANDACurrent
11673-909up and up naproxen sodiumnaproxen sodiumTarget CorporationANDACurrent
11822-0140Naproxen SodiumNaproxen sodiumRite Aid CorporationANDACurrent
11822-0140Naproxen SodiumNaproxen sodiumRite Aid CorporationANDACurrent
11822-0140Naproxen SodiumNaproxen sodiumRite Aid CorporationANDACurrent
11822-0490naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0490naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0490naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0490naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0507naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0507naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0507naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-0507naproxen sodiumNaproxen SodiumRite Aid CorporationANDACurrent
11822-1330back and muscle painNaproxen SodiumRite Aid CorporationANDACurrent
11822-1330back and muscle painNaproxen SodiumRite Aid CorporationANDACurrent
21130-016Signature Care Pain ReliefNaproxen SodiumSafewayANDACurrent
21130-016Signature Care Pain ReliefNaproxen SodiumSafewayANDACurrent
21130-180signature care naproxen sodiumNaproxen SodiumSafewayANDACurrent
21130-180signature care naproxen sodiumNaproxen SodiumSafewayANDACurrent
21130-180signature care naproxen sodiumNaproxen SodiumSafewayANDACurrent
21130-180signature care naproxen sodiumNaproxen SodiumSafewayANDACurrent
21130-187Signature Care Naproxen SodiumNaproxen SodiumSafewayANDACurrent
21130-187Signature Care Naproxen SodiumNaproxen SodiumSafewayANDACurrent
21130-444Signature Care Pain ReliefNaproxen SodiumSafewayANDACurrent
21130-444Signature Care Pain ReliefNaproxen SodiumSafewayANDACurrent
21130-507signature care pain reliefNaproxen sodiumSafewayANDACurrent
21130-802signature care naproxen sodiumNaproxen sodiumSafewayANDACurrent
21130-802signature care naproxen sodiumNaproxen sodiumSafewayANDACurrent
21130-802signature care naproxen sodiumNaproxen sodiumSafewayANDACurrent
21695-088Naproxen Pain ReliefNaproxen SodiumRebel Distributors CorpANDACurrent
24385-490Good Neighbor Pharmacy naproxen sodiumNaproxen SodiumAmerisource BergenANDACurrent
24385-490Good Neighbor Pharmacy naproxen sodiumNaproxen SodiumAmerisource BergenANDACurrent
30142-177Naproxen SodiumNaproxen sodiumKroger CompanyANDACurrent
30142-177Naproxen SodiumNaproxen sodiumKroger CompanyANDACurrent
30142-177Naproxen SodiumNaproxen sodiumKroger CompanyANDACurrent
30142-500Naproxen SodiumNaproxen SodiumKroger CompanyANDACurrent