FDA.reportPublic FDA data

Application 071267

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 37 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.88795f0e-41b7-504e-e053-2995a90a3b9e2024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen, Circle K, 50ctIBUPROFENLil' Drug Store Products, Inc.1ab6fbae-ead5-283b-e063-6394a90a4ed42024-06-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC114b5e23-6cd7-41d8-e063-6294a90aa0f02024-06-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.6d86ce94-a06a-2769-e053-2991aa0afb952024-06-10Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.6365b2d6-2337-70c0-e053-2a91aa0aa9602024-06-06Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENBoswell Pharmacy Services LLC d/b/a BPS Wholesale1a02fa34-b5ae-7183-e063-6294a90a3ae42024-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENSKYA HEALTH, LLC1c28af16-7246-4e4c-a1be-939655c372422024-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENSAM'S WEST INC16595d75-6e74-0839-e063-6394a90abc132024-05-28WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen, Lil Drug StoreIBUPROFENLil' Drug Store products, Inc.18e80dab-6837-fd2d-e063-6294a90a73c82024-05-20WarningsName fallback
generic name: IBUPROFEN
IBUPROFEN 100IBUPROFENJHK Inc dba American Safety & First Aid218f6df9-dd04-45b6-8a45-3276691abee22024-04-25WarningsName fallback
generic name: IBUPROFEN
JUNIOR STRENGTH ADVILIBUPROFENHaleon US Holdings LLC5ed0d404-c54d-b05f-578a-d2730e8a78ee2024-04-22WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENKroger Companybc178013-ab2e-04f5-e053-2995a90a1ed42024-04-13WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFEN TABLETS USP, 200MGKROGER COMPANY0fbe42d0-b5f2-0780-e063-6394a90a4ecb2024-04-13WarningsName fallback
brand name: Ibuprofen
IbuprofenIBUPROFENKROGER COMPANY0fbe42d0-b5f0-0780-e063-6394a90a4ecb2024-04-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
dg health ibuprofenIBUPROFENDolgencorp Incb514b589-d965-4a21-91b3-fab4019e9d962024-04-12WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENH E Be00acbc0-352e-4ba1-8433-18a3079f67432024-04-12WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
Infants IbuprofenIBUPROFENAurohealth LLC2a48af51-23e2-4fec-a76b-eef1611750f52024-04-10WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENSam's West, Inc74ad11b9-8976-463d-89a3-2b9f5acd0c802024-04-01WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Advil Liqui-GelsIBUPROFENLil Drug Store Products, Incba5a9a04-993e-4fd6-bb40-6edfdfb69b342024-03-27WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.141b7964-cce6-74e4-e063-6294a90af7462024-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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