FDA.reportPublic FDA data

Application 200674

Type
ANDA
Sponsor
FRESENIUS KABI USA

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
63323-355LevofloxacinLEVOFLOXACINFresenius Kabi USA, LLCANDACurrent
63323-355LevofloxacinLEVOFLOXACINFresenius Kabi USA, LLCANDACurrent
63323-355LevofloxacinLEVOFLOXACINFresenius Kabi USA, LLCANDACurrent