FDA.reportPublic FDA data

Application 211080

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL48MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL145MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-430FENOFIBRATEfenofibrateSolco Healthcare US, LLCANDACurrent
43547-430FENOFIBRATEfenofibrateSolco Healthcare US, LLCANDACurrent
43547-431FENOFIBRATEfenofibrateSolco Healthcare US, LLCANDACurrent
43547-431FENOFIBRATEfenofibrateSolco Healthcare US, LLCANDACurrent