FDA.reportPublic FDA data

Application 076520

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL54MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL107MGNoNo
003FENOFIBRATEFENOFIBRATETABLET;ORAL160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7100FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7100FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7100FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7100FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7100FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7101FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7101FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7101FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7101FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7101FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
42043-170FenofibrateFenofibrateKaralex Pharma LLCANDACurrent
42043-171FenofibrateFenofibrateKaralex Pharma LLCANDACurrent
43353-898FenofibratefenofibrateAphena Pharma Solutions - Tennessee, LLCANDACurrent