FDA.reportPublic FDA data

Application 202252

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL43MGNoNo
002FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL130MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3120FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3120FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3120FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3120FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3120FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3120FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3121FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3121FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3121FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3121FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3121FenofibrateFenofibrateApotex Corp.ANDACurrent
60505-3121FenofibrateFenofibrateApotex Corp.ANDACurrent