FDA.reportPublic FDA data

Application 078523

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALPROATE SODIUMVALPROATE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9637Valproate SodiumValproate SodiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9637Valproate SodiumValproate SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9785Valproate SodiumValproate SodiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9785Valproate SodiumValproate SodiumHikma Pharmaceuticals USA Inc.ANDACurrent