Application 078736

Type
ANDA
Sponsor
MYLAN LABS LTD

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
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-516Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent
67457-517Fosphenytoin SodiumFosphenytoin SodiumMylan Institutional LLCANDACurrent