Application 213834

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL100MG EXTENDEDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-379Phenytoin SodiumPhenytoin SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent