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 40 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.ba0baba6-a7f9-4e4c-88f7-c7fbecc61f252023-10-25WarningsName fallback
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2b9e71c5-9b32-4b1b-a479-e5457a1f9afd2023-10-16WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENMeijer Distribution Ince578de96-747e-4104-8db6-e6521e6052a52023-10-09WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAsclemed USA, Inc.793e4b36-8208-4fa3-9f4f-9e9e726482802023-10-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack8fafa916-733a-4c7d-99da-6ca2ed54e1e42023-10-06WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYfed2f7ae-2825-f967-e053-6294a90adc0a2023-10-05WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENStrategic Sourcing Services LLC9f020645-ba77-49e1-b9f1-0e36cdf26adb2023-10-05WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb613c44-e125-0f40-e053-2995a90a7ca52023-10-02WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb60e636-41fe-49fb-e053-2a95a90a06162023-09-29WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Signature Care IbuprofenIBUPROFENSafeway93edca03-fdf1-453f-8efe-5f0b8eef41e42023-09-28WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBetter Living Brands LLCf6ef7f73-b5ab-4c82-e053-6394a90ac81e2023-09-22WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFEN CAPSULES 200 MGTIME CAP LABORATORIES, INC.c7c51cf3-9e95-f8d0-e053-2995a90a73712023-09-18WarningsName fallback
brand name: Ibuprofen
Ibuprofen MinisIBUPROFENAurohealth LLCd0b03d99-477f-4250-ac84-576b1baf2eed2023-09-15WarningsName fallback
generic name: IBUPROFEN
Dolex FlexIBUPROFENPharmadel LLC822d9def-504c-9beb-e053-2991aa0a280e2023-09-13WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutionse4644cb5-7fae-456a-98d3-62ba521cd0b22023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions408c977c-2cf7-4175-877d-d221ed49248a2023-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions1991c503-ef6e-42dc-ada4-f909962dd7892023-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBest Choice (Valu Merchandisers Company)04b4ed2b-5f43-4151-b355-ca1bb469658d2023-08-31WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutionsfa99f5ec-0306-473b-827f-86cd0a7978ec2023-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENCare One (Retail Business Services, LLC.)b5e9bd39-d2c5-4a6c-b0da-8e41d633b31c2023-08-24WarningsName fallback
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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