FDA.reportPublic FDA data

Application 209950

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

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
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent