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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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