FDA.reportPublic FDA data

Application 202856

Type
ANDA
Sponsor
MYLAN PHARMS 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
0378-3065FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3065FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3065FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3065FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3066FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3066FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3066FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3066FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
51079-599FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-599FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-599FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-599FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-599FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-608FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-608FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-608FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-608FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
51079-608FenofibratefenofibrateMylan Institutional Inc.ANDACurrent
68071-2686FenofibratefenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7932FenofibratefenofibratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7932FenofibratefenofibratePreferred Pharmaceuticals Inc.ANDACurrent
71335-2016FenofibratefenofibrateBryant Ranch PrepackANDACurrent