FDA.reportPublic FDA data

Application 212598

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
50090-5369FENOFIBRIC ACIDFENOFIBRIC ACIDA-S Medication SolutionsANDACurrent
59651-216FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-216FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-216FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-216FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-217FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-217FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-217FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent
59651-217FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma LimitedANDACurrent