FDA.reportPublic FDA data

Application 020163

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo
002DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo
003DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporaNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0426DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporaNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0427DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporaNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent
0941-0429DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74451SUPPL 2023-06-06
74443SUPPL 2023-06-06
45073SUPPL2016-08-17
45139SUPPL2016-08-16
34327SUPPL2015-09-04
2113SUPPL2015-09-04
12284SUPPL2015-02-10
2112SUPPL2015-02-10
21235SUPPL2013-04-24
34326SUPPL2013-04-23
21234SUPPL2005-08-11
2111SUPPL2005-08-11