FDA.reportPublic FDA data

Application 208709

Type
ANDA
Sponsor
CIPLA

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
0904-7161FENOFIBRATEFENOFIBRATEMajor PharmaceuticalsANDACurrent
50090-4031FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
50090-4031FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
50090-5327FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
50090-5327FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
68071-4557FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4988FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4988FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5101FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5101FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7579FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7579FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7579FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7579FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals, Inc.ANDACurrent
69097-458FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-458FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-458FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-458FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-458FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-458FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-459FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-459FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-459FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-459FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-459FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
69097-459FENOFIBRATEFENOFIBRATECipla USA Inc.ANDACurrent
71335-0891FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent
71335-0891FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent
71335-0891FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent
71335-1211FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent