FDA.reportPublic FDA data

Application 206919

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-243LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-243LevofloxacinLevofloxacin in 5% DextroseAuroMedics Pharma LLCANDACurrent
55150-243LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-243LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-244LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-244LevofloxacinLevofloxacin in 5% DextroseAuroMedics Pharma LLCANDACurrent
55150-244LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-244LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-245LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-245LevofloxacinLevofloxacin in 5% DextroseAuroMedics Pharma LLCANDACurrent
55150-245LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-245LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent