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 7 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.027ded51-aa01-6619-3938-c8162a421cf32026-06-18WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen Bubblegum Dye FreeIBUPROFENCVS2cf2f35b-5d66-e3ff-e063-6294a90a9b452026-06-16WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENGranules India Limited97516b9f-219a-429d-850d-1fe9fd66646b2026-06-15WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENCardinal Health 110, LLC. DBA Leadera41a0bc2-ef7a-44cd-a42e-aefab41323cc2026-06-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE01f8fe3a-8810-4b38-8860-d95e05d377092026-06-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENREMEDYREPACK INC.2fa4bfc8-386c-433b-bc46-24fc8ec1bca12026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthwind Health Company, LLCab80abe6-f7db-479b-e053-2a95a90a90e32026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENREMEDYREPACK INC.ec6b2df4-2f4f-4601-8b53-0542664e0bd92026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.57b39311-bc20-ace6-75a9-a07a9311b3732026-06-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENRite Aid Corporationd9e698f3-c450-4eaa-9cfd-6f48c26560812026-06-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE718a4b73-5f46-4676-afda-f0b4819f58622026-06-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.68988a5b-7a6a-4ecd-8006-f2610bac2ad72026-06-08WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENP & L Development, LLCd0301d0d-fc65-420f-87fd-a08da1584d542026-06-08WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAurohealth LLC43c94480-78d1-4a23-91d4-1d49fea72cb72026-06-05WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen MinisIBUPROFENVivunt Pharma LLCc46803db-feb7-435c-ac42-cffa99d35f462026-06-04WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENMedline industries, LP5d2482b4-cd90-4246-85a9-fd1d35315b6c2026-06-04WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Basic Care IbuprofenIBUPROFENAmazon.com Services LLC4c1a1543-a2a2-43fb-901c-cf6bcc374a3f2026-06-03WarningsName fallback
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENCVS Pharmacy6d047655-2b29-4f74-ac6e-93b02c25870c2026-06-01WarningsName fallback
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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