FDA.reportPublic FDA data

Application 211420

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINESUSPENSION;ORAL300MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-312OxcarbazepineOxcarbazepineAkornANDACurrent
50383-312OxcarbazepineOxcarbazepineHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-312OxcarbazepineOxcarbazepineAkornANDACurrent