FDA.reportPublic FDA data

Application 211856

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHOLESTYRAMINECHOLESTYRAMINEPOWDER;ORALEQ 4GM RESIN/PACKETNoNo
002CHOLESTYRAMINECHOLESTYRAMINEPOWDER;ORALEQ 4GM RESIN/SCOOPFULNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-9196cholestyramine powder for suspensioncholestyramine powder for suspensionBryant Ranch PrepackANDACurrent
63629-9196cholestyramine powder for suspensioncholestyramine powder for suspensionBryant Ranch PrepackANDACurrent
63629-9196cholestyramine powder for suspensioncholestyramine powder for suspensionBryant Ranch PrepackANDACurrent
63629-9197cholestyramine powder for suspensioncholestyramine powder for suspensionBryant Ranch PrepackANDACurrent
63629-9197cholestyramine powder for suspensioncholestyramine powder for suspensionBryant Ranch PrepackANDACurrent
67877-298cholestyramine powder for suspensioncholestyramine powder for suspensionAscend Laboratories, LLCANDACurrent
67877-298cholestyramine powder for suspensioncholestyramine powder for suspensionAscend Laboratories, LLCANDACurrent