FDA.reportPublic FDA data

Application 210670

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL54MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-909FenofibrateFENOFIBRATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-909FenofibrateFENOFIBRATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-909FenofibrateFENOFIBRATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-910FenofibrateFENOFIBRATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-910FenofibrateFENOFIBRATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-910FenofibrateFENOFIBRATEDr. Reddy's Laboratories Inc.ANDACurrent
50090-5158FenofibrateFENOFIBRATEA-S Medication SolutionsANDACurrent
50090-5158FenofibrateFENOFIBRATEA-S Medication SolutionsANDACurrent
70518-3370FenofibrateFENOFIBRATEREMEDYREPACK INC.ANDACurrent