FDA.reportPublic FDA data

Application 091375

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 250MG/50ML (EQ 5MG/ML)NoNo
002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 500MG/100ML (EQ 5MG/ML)NoNo
003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 750MG/150ML (EQ 5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9315LevofloxacinLevofloxacinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9315LevofloxacinLevofloxacinWest-Ward PharmaceuticalsANDACurrent
0143-9316LevofloxacinLevofloxacinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9316LevofloxacinLevofloxacinWest-Ward PharmaceuticalsANDACurrent
0143-9317LevofloxacinLevofloxacinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9317LevofloxacinLevofloxacinWest-Ward PharmaceuticalsANDACurrent
0143-9720LevofloxacinLevofloxacinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9720LevofloxacinLevofloxacinWest-Ward PharmaceuticalsANDACurrent
0143-9721LevofloxacinLevofloxacinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9721LevofloxacinLevofloxacinWest-Ward PharmaceuticalsANDACurrent
0143-9722LevofloxacinLevofloxacinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9722LevofloxacinLevofloxacinWest-Ward PharmaceuticalsANDACurrent