FDA.reportPublic FDA data

Application 203931

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBEEZETIMIBETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5690EzetimibeEzetimibeSandoz IncANDACurrent
0781-5690EzetimibeEzetimibeSandoz IncANDACurrent
63629-7413EzetimibeEzetimibeBryant Ranch PrepackANDACurrent
70518-3334EzetimibeEzetimibeREMEDYREPACK INC.ANDACurrent
71205-145EzetimibeEzetimibeProficient Rx LPANDACurrent
71205-145EzetimibeEzetimibeProficient Rx LPANDACurrent