FDA.reportPublic FDA data

Application 204598

Type
ANDA
Sponsor
HETERO LABS LTD III

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
31722-595FenofibrateFenofibrateCamber Pharmaceuticals, Inc.ANDACurrent
31722-596FenofibrateFenofibrateCamber Pharmaceuticals, Inc.ANDACurrent
50090-3044FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-3044FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-3056FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
68071-2587FenofibrateFenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8106FenofibrateFenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8106FenofibrateFenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
70934-508FenofibrateFenofibrateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-567FenofibrateFenofibrateDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent