FDA.reportPublic FDA data

Application 202328

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACININJECTABLE;INJECTIONEQ 500MG/20ML (EQ 25MG/ML)NoYes
002LEVOFLOXACINLEVOFLOXACININJECTABLE;INJECTIONEQ 750MG/30ML (EQ 25MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-156LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-156LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-156LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-157LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-157LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent
55150-157LevofloxacinLevofloxacinAuroMedics Pharma LLCANDACurrent