FDA.reportPublic FDA data

Application 201193

Type
ANDA
Sponsor
HIKMA

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
0054-0199OxcarbazepineOxcarbazepineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0199OxcarbazepineOxcarbazepineWest-Ward Pharmaceuticals Corp.ANDACurrent