FDA.reportPublic FDA data

Application 050724

Type
NDA
Sponsor
LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABELCETAMPHOTERICIN BINJECTABLE, LIPID COMPLEX;INJECTION5MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent