FDA.reportPublic FDA data

Application 090343

Type
ANDA
Sponsor
INFORLIFE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-825LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-825LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent