FDA.reportPublic FDA data

Application 040573

Type
ANDA
Sponsor
ACELLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOIN SODIUMPHENYTOIN SODIUMINJECTABLE;INJECTION50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-4050PHENYTOIN SODIUMPHENYTOIN SODIUMX-GEN Pharmaceuticals, Inc.ANDACurrent
42192-614PHENYTOIN SODIUMPHENYTOIN SODIUMAcella Pharmaceuticals, LLCANDACurrent
42192-614PHENYTOIN SODIUMPHENYTOIN SODIUMAcella Pharmaceuticals, LLCANDACurrent