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 11 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENLidl US LLCb840e98e-be1b-496f-9f0d-3a1a55eb9fe42026-04-08WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
good sense childrens ibuprofenIBUPROFENL. Perrigo Company19253175-4185-468d-9d3d-9b53be764e182026-04-07WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.0ef4913b-5dc3-45bc-9cef-58601f8d2a792026-04-07WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen Dye-FreeIBUPROFENWal-Mart Stores Inc23cb5001-6aeb-434a-b2e8-aaf8bbab9dc62026-04-01WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack1ebf94fb-76b6-4c01-be1b-5750628275452026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFEN ORALAurobindo Pharma Limited758eeb45-e599-4c1a-969d-8fa33f27bf142026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
Ibuprofen Dye FreeIBUPROFENWALMART INC.2b04d255-a1df-4698-9b5a-ad7a12205e1b2026-03-25WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.32edaf34-046e-4ded-8bee-493a0019d6bd2026-03-25WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENREMEDYREPACK INC.dda7645f-1666-4c1f-b974-01add2ea79ac2026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFEN InfantsIBUPROFENSun Pharmaceutical Industries, Inc.bc816597-a85a-4143-9f99-bb0699ca57c52026-03-23WarningsName fallback
generic name: IBUPROFEN
Dolex FlexIBUPROFENPharmadel LLC0543420d-a250-065d-e063-6294a90a005e2026-03-20WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENWestminster Pharmaceuticals, LLC6f7e255f-48c9-4366-8725-7f8cbe1bb75a2026-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthStar Rx LLCaeee629b-255c-40d8-8e95-779aec00f7232026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENAdvagen Pharma Ltd.4b8b06f3-8557-4645-af27-c0819e163b792026-03-12WarningsName fallback
generic name: IBUPROFEN
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENWalgreen Company86818ad6-fd45-4635-9ce8-eac986f008aa2026-03-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENDiscount Drug Martd0ebf2a7-551b-4acd-be60-2d0b936dd7032026-03-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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