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 47 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen ChildrensIBUPROFENH E B0a9a54ce-572f-4a96-922f-cc136d2d4aad2018-06-07WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBreeden Brothers, LLCe4314153-479d-4c0f-ba49-4d4efded304b2018-04-06WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPuraCap Pharmaceutical LLCacc4cbc8-085d-42f3-ad93-113e0b55631c2017-11-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCVS PHARMACY, INC.cdd5a402-df90-4a16-a38c-78eab71899982017-11-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Fast Pain ReliefIBUPROFENHealthLife of USA LLCa3fcd34a-6aa9-477c-bbfb-2f6b36e06b652017-06-05WarningsName fallback
generic name: IBUPROFEN
Dye Free IbuprofenIBUPROFENBreeden Brothers, LLCba106f6f-2c6b-4c98-a10e-d27622b08b252017-02-15WarningsName fallback
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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