FDA.reportPublic FDA data

Application 090981

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/5ML (100MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9574LevetiracetamLevetiracetamHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9574LevetiracetamLevetiracetamWest-Ward Pharmaceuticals CorpANDACurrent
0143-9673LevetiracetamLevetiracetamHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9673LevetiracetamLevetiracetamHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9673LevetiracetamLevetiracetamWest-Ward Pharmaceuticals CorpANDACurrent
72572-360LevetiracetamLevetiracetamCivica, Inc.ANDACurrent