FDA.reportPublic FDA data

Application 210469

Type
ANDA
Sponsor
TWI PHARMS

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
24979-109Fenofibric AcidFenofibric AcidTWi Pharmaceuticals, Inc.ANDACurrent
24979-112Fenofibric AcidFenofibric AcidTWi Pharmaceuticals, Inc.ANDACurrent