FDA.reportPublic FDA data

Application 204019

Type
ANDA
Sponsor
LUPIN LTD

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
0615-8165FenofibrateFenofibrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8165FenofibrateFenofibrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6810FenofibrateFenofibrateMajor PharmaceuticalsANDACurrent
0904-6810FenofibrateFenofibrateMajor PharmaceuticalsANDACurrent
0904-6810FenofibrateFenofibrateMajor PharmaceuticalsANDACurrent
0904-7128FenofibrateFenofibrateMajor PharmaceuticalsANDACurrent
50090-2546FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-2546FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-3842FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-3842FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-5854FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-6227FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
63187-681FenofibrateFenofibrateProficient Rx LPANDACurrent
63187-681FenofibrateFenofibrateProficient Rx LPANDACurrent
68071-2021FenofibrateFenofibrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4264FenofibrateFenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4264FenofibrateFenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68180-231FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-231FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-232FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-232FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-362FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-362FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-362FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-362FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-362FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-363FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-363FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-363FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-363FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-363FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68788-6330FenofibrateFenofibratePreferred Pharmaceuticals Inc.ANDACurrent
68788-6330FenofibrateFenofibratePreferred Pharmaceuticals Inc.ANDACurrent
70518-0700FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-0700FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-0700FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-0700FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-1988FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-1988FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-1988FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70518-1988FenofibrateFenofibrateREMEDYREPACK INC.ANDACurrent
70934-591FenofibrateFenofibrateDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-366FenofibrateFenofibrateProficient Rx LPANDACurrent
72189-026FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent
72189-026FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent
72189-026FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent
72189-026FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent