FDA.reportPublic FDA data

Application 090876

Type
ANDA
Sponsor
FRESENIUS KABI USA

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
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent
63323-400LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCANDACurrent