FDA.reportPublic FDA data

Application 040610

Type
ANDA
Sponsor
VISTAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOINPHENYTOINSUSPENSION;ORAL125MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64950-231PhenytoinPhenytoinGenus Lifesciences Inc.ANDACurrent
66689-775PhenytoinPhenytoinVistaPharm, Inc.ANDACurrent
66689-775PhenytoinPhenytoinVistaPharm, Inc.ANDACurrent
66689-775PhenytoinPhenytoinVistaPharm, Inc.ANDACurrent
66689-775PhenytoinPhenytoinVistaPharm, Inc.ANDACurrent
66689-775PhenytoinPhenytoinVistaPharm, Inc.ANDACurrent
66689-775PhenytoinPhenytoinVistaPharm, Inc.ANDACurrent
70518-2554PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-3353PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent