FDA.reportPublic FDA data

Application 200920

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDNoNo
002FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2838fenofibric acidfenofibric acidActavis Pharma, Inc.ANDACurrent
0228-2839fenofibric acidfenofibric acidActavis Pharma, Inc.ANDACurrent