FDA.reportPublic FDA data

Application 040731

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL200MG EXTENDEDNoNo
002EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL300MG EXTENDEDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-299phenytoin sodiumphenytoin sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-299phenytoin sodiumphenytoin sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-299phenytoin sodiumphenytoin sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-432phenytoin sodiumphenytoin sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-432phenytoin sodiumphenytoin sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-432phenytoin sodiumphenytoin sodiumSun Pharmaceutical Industries, Inc.ANDACurrent