FDA.reportPublic FDA data

Application 091485

Type
ANDA
Sponsor
XGEN PHARMS

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
39822-4000LevetiracetamLevetiracetamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-4000LevetiracetamLevetiracetamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-4000LevetiracetamLevetiracetamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-4000LevetiracetamLevetiracetamXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-4000LevetiracetamLevetiracetamXGen Pharmaceuticals DJB, Inc.ANDACurrent