FDA.reportPublic FDA data

Application 204475

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL40MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4390FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4390FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4390FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4390FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4391FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4391FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4391FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent
0378-4391FenofibratefenofibrateMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40394ORIG2016-06-27
10346ORIG2016-06-24