FDA.reportPublic FDA data

Application 090038

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MILRINONE LACTATE IN PLASTIC CONTAINERMILRINONE LACTATEINJECTABLE;INJECTIONEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)NoNo
002MILRINONE LACTATE IN PLASTIC CONTAINERMILRINONE LACTATEINJECTABLE;INJECTIONEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9718Milrinone Lactate in DextroseMilrinone Lactate in DextroseHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9718Milrinone Lactate in DextroseMilrinone Lactate in DextroseWest-Ward Pharmaceuticals CorpANDACurrent
0143-9719Milrinone Lactate in DextroseMilrinone Lactate in DextroseHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9719Milrinone Lactate in DextroseMilrinone Lactate in DextroseWest-Ward Pharmaceuticals CorpANDACurrent