FDA.reportPublic FDA data

Application 075834

Type
ANDA
Sponsor
BAXTER HLTHCARE

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)NoYes
002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEINJECTABLE;INJECTIONEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-6010Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6010Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6010Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6010Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6011Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6011Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6011Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent
0338-6011Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39493ORIG2003-12-24
22510ORIG2003-12-24
8801ORIG2003-12-24