Application 078765

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSPHENYTOIN SODIUMFOSPHENYTOIN SODIUMINJECTABLE;INJECTIONEQ 50MG PHENYTOIN NA/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9782Fosphenytoin SodiumFosphenytoin SodiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9788Fosphenytoin SodiumFosphenytoin SodiumWest-Ward Pharmaceuticals CorpANDACurrent