FDA.reportPublic FDA data

Application 213585

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEINJECTABLE;INJECTIONEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)NoNo
002MILRINONE LACTATE IN DEXTROSE 5% 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
0409-1983Milrinone Lactate in DextroseMilrinone Lactate in DextroseHospira, Inc.ANDACurrent
0409-1983Milrinone Lactate in DextroseMilrinone Lactate in DextroseHospira, Inc.ANDACurrent
0409-2045Milrinone Lactate in DextroseMilrinone Lactate in DextroseHospira, Inc.ANDACurrent
25021-313Milrinone Lactate in DextroseMilrinone LactateSagent PharmaceuticalsANDACurrent
68083-410Milrinone Lactate in DextroseMilrinone LactateGland Pharma LimitedANDACurrent
68083-410Milrinone Lactate in DextroseMilrinone LactateGland Pharma LimitedANDACurrent
68083-411Milrinone Lactate in DextroseMilrinone LactateGland Pharma LimitedANDACurrent
68083-411Milrinone Lactate in DextroseMilrinone LactateGland Pharma LimitedANDACurrent