FDA.reportPublic FDA data

Application 215184

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOLAZONEMETOLAZONETABLET;ORAL2.5MGNoNo
002METOLAZONEMETOLAZONETABLET;ORAL5MGNoNo
003METOLAZONEMETOLAZONETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72888-052METOLAZONEMETOLAZONEAdvagen Pharma LimitedANDACurrent
72888-052METOLAZONEMETOLAZONEAdvagen Pharma LimitedANDACurrent
72888-053METOLAZONEMETOLAZONEAdvagen Pharma LimitedANDACurrent
72888-053METOLAZONEMETOLAZONEAdvagen Pharma LimitedANDACurrent
72888-054METOLAZONEMETOLAZONEAdvagen Pharma LimitedANDACurrent
72888-054METOLAZONEMETOLAZONEAdvagen Pharma LimitedANDACurrent