FDA.reportPublic FDA data

Application 215304

Type
ANDA
Sponsor
JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GADOTERATE MEGLUMINEGADOTERATE MEGLUMINESOLUTION;INTRAVENOUS1.8845GM/5ML (376.9MG/ML)NoNo
002GADOTERATE MEGLUMINEGADOTERATE MEGLUMINESOLUTION;INTRAVENOUS3.769GM/10ML (376.9MG/ML)NoNo
003GADOTERATE MEGLUMINEGADOTERATE MEGLUMINESOLUTION;INTRAVENOUS5.6535GM/15ML (376.9MG/ML)NoNo
004GADOTERATE MEGLUMINEGADOTERATE MEGLUMINESOLUTION;INTRAVENOUS7.538GM/20ML (376.9MG/ML)NoNo
005GADOTERATE MEGLUMINEGADOTERATE MEGLUMINESOLUTION;INTRAVENOUS37.69GM/100ML (376.9MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65219-080Gadoterate Megluminegadoterate meglumineFresenius Kabi USA, LLCANDACurrent
65219-082Gadoterate Megluminegadoterate meglumineFresenius Kabi USA, LLCANDACurrent
65219-084Gadoterate Megluminegadoterate meglumineFresenius Kabi USA, LLCANDACurrent
65219-086Gadoterate Megluminegadoterate meglumineFresenius Kabi USA, LLCANDACurrent