FDA.reportPublic FDA data

Application 205540

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-394LEVOFLOXACINLEVOFLOXACINGland Pharma LimitedANDACurrent
68083-395LEVOFLOXACINLEVOFLOXACINGland Pharma LimitedANDACurrent