FDA.reportPublic FDA data

Application 078476

Type
ANDA
Sponsor
AMNEAL

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
65162-998Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-998Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-998Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-999Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-999Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-999Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals of New York, LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal BiosciencesANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal BiosciencesANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent