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 31 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye Free Childrens IbuprofenIBUPROFENPrecision Dose Inc.eccee4c6-aa94-468a-aebd-265d7a9efb6d2025-02-12WarningsName fallback
generic name: IBUPROFEN
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBrisk Pharmaceuticals2dcbe4bb-fb24-e827-e063-6394a90acf9f2025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen infants DropsIBUPROFENHarris Teeter, LLC2c39a24f-4e42-d75f-e063-6394a90a60fa2025-02-04WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fae53f7b-3948-2566-e053-6394a90aae362025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENHarris Teeter, LLC2bb186c8-f791-5f1f-e063-6294a90a87ff2025-02-04WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.0bee69ff-cf76-175e-e063-6294a90a42f62025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBi-Mart7ceacd63-d5fa-4cab-b8f3-a5131c97bb902025-02-01WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBI-MART34440532-03e1-4feb-b3e2-dab869edeb152025-02-01WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Dye Free Childrens IbuprofenIBUPROFENPAI Holdings, LLC dba PAI Pharmaa616a7cd-4814-478e-8c58-7fbc2454d9922025-01-31WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd2457c045-0b7c-48f4-9422-11623f13d8f12025-01-29WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPLD Acquisitions LLC DBA Avma Pharma Solutionsc6dcc329-bab5-41ab-94e7-625e07628fd62025-01-28WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
AdvilIBUPROFENLil' Drug Store Products, Inc.772360bd-8631-4d24-b4db-5a7e6e1d9a132025-01-27WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltdefb728f2-fe74-4833-8f0c-710d833abf6e2025-01-27WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENDirect Rxd88d0544-57a7-4a82-e053-2a95a90a19452025-01-21Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension, Dye FreeIBUPROFENBest Choice55fd05c7-b902-4c82-ab9a-8054d880dfbd2025-01-20WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENDIRECT RXc3f30813-0848-6e8a-e053-2995a90a3dea2025-01-20Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension, Bubble GumIBUPROFENBest Choiced27ca801-d4d3-4fd0-a22b-db5ada5fcb9f2025-01-20WarningsName fallback
generic name: IBUPROFEN
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb2025-01-13Boxed 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.