FDA.reportPublic FDA data

Application 209666

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MILRINONE LACTATE IN DEXTROSE 5%MILRINONE LACTATEINJECTABLE;INJECTIONEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)NoNo
002MILRINONE LACTATE IN DEXTROSE 5%MILRINONE LACTATEINJECTABLE;INJECTIONEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-287Milrinone LactateMilrinone LactateAuroMedics Pharma LLCANDACurrent
55150-287Milrinone LactateMilrinone LactateAuroMedics Pharma LLCANDACurrent
55150-287Milrinone LactateMilrinone LactateAuroMedics Pharma LLCANDACurrent
55150-287Milrinone LactateMilrinone Lactate in 5% DextroseAuroMedics Pharma LLCANDACurrent
55150-288Milrinone LactateMilrinone LactateAuroMedics Pharma LLCANDACurrent
55150-288Milrinone LactateMilrinone LactateAuroMedics Pharma LLCANDACurrent
55150-288Milrinone LactateMilrinone LactateAuroMedics Pharma LLCANDACurrent
55150-288Milrinone LactateMilrinone Lactate in 5% DextroseAuroMedics Pharma LLCANDACurrent