FDA.reportPublic FDA data

Application 213532

Type
ANDA
Sponsor
NEXUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/100ML (5MG/ML)NoNo
002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1000MG/100ML (10MG/ML)NoNo
003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1500MG/100ML (15MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14789-110Levetiracetam in Sodium ChlorideLevetiracetamNexus Pharmaceuticals IncANDACurrent
14789-110Levetiracetam in Sodium ChlorideLevetiracetamNexus Pharamaceuticals Inc.ANDACurrent
14789-220Levetiracetam in Sodium ChlorideLevetiracetamNexus Pharmaceuticals IncANDACurrent
14789-220Levetiracetam in Sodium ChlorideLevetiracetamNexus Pharamaceuticals Inc.ANDACurrent
14789-330Levetiracetam in Sodium ChlorideLevetiracetamNexus Pharmaceuticals IncANDACurrent
14789-330Levetiracetam in Sodium ChlorideLevetiracetamNexus Pharamaceuticals Inc.ANDACurrent