FDA.reportPublic FDA data

Application 200750

Type
ANDA
Sponsor
LUPIN 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
50090-4373Fenofibric acidFenofibric acidA-S Medication SolutionsANDACurrent
50090-4373Fenofibric acidFenofibric acidA-S Medication SolutionsANDACurrent
68180-128Fenofibric acidFenofibric acidLupin Pharmaceuticals, Inc.ANDACurrent
68180-128Fenofibric acidFenofibric acidLupin Pharmaceuticals, Inc.ANDACurrent
68180-128Fenofibric acidFenofibric acidLupin Pharmaceuticals, Inc.ANDACurrent
68180-129Fenofibric acidFenofibric acidLupin Pharmaceuticals, Inc.ANDACurrent
68180-129Fenofibric acidFenofibric acidLupin Pharmaceuticals, Inc.ANDACurrent
68180-129Fenofibric acidFenofibric acidLupin Pharmaceuticals, Inc.ANDACurrent