FDA.reportPublic FDA data

Application 020183

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo
002DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo
003DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo
004DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporaNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporaNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0430DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporaNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0433DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74450SUPPL 2023-06-06
74449SUPPL 2023-06-06
45072SUPPL2016-08-17
45140SUPPL2016-08-16
12305SUPPL2015-09-04
2149SUPPL2015-09-04
34350SUPPL2015-02-10
2148SUPPL2015-02-10
24544SUPPL2013-04-24
12304SUPPL2013-04-23
20528SUPPL2007-11-19
24543SUPPL2005-08-11
2147SUPPL2005-08-11