FDA.reportPublic FDA data

Application 074557

Type
ANDA
Sponsor
SANDOZ

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0940CholestyramineCholestyramineEon Labs, Inc.ANDACurrent
0185-0940CholestyramineCholestyramineEon Labs, Inc.ANDACurrent
0185-0940CholestyramineCholestyramineEon Labs, Inc.ANDACurrent
0245-0536CholestyramineCholestyramineUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0536CholestyramineCholestyramineUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0536CholestyramineCholestyramineUpsher-Smith Laboratories, Inc.ANDACurrent
42806-265CHOLESTYRAMINEcholestyramineEPIC PHARMA, LLCANDACurrent
42806-266CHOLESTYRAMINEcholestyramineEPIC PHARMA, LLCANDACurrent
42806-267CHOLESTYRAMINEcholestyramineEPIC PHARMA, LLCANDACurrent