← FDA DRUG APPROVALS
FDA NDA · NDA017512
DIANEAL LOW CALCIUM WITH DEXTROSE
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Sponsor: VANTIVE US HLTHCARE
APPLICATION
NDA017512
TYPE
NDA
ORIGINAL APPROVAL
1978-09-27
LATEST ACTION
2016-12-09
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued
Products
DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.3MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.3MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER · ReferenceDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 3.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.3MG/100ML, DEXTROSE 3.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.3MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 3.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
Approval history
2016-12-09Manufacturing (CMC) · Supplement 125 · standardAP
2016-08-16Labeling · Supplement 123 · standardAP
2016-08-01Manufacturing (CMC) · Supplement 124 · standardAP
2015-05-22Manufacturing (CMC) · Supplement 119 · standardAP
2014-09-30Manufacturing (CMC) · Supplement 117 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 116 · standardAP
2002-09-20Manufacturing (CMC) · Supplement 99 · standardAP
2001-08-22Manufacturing (CMC) · Supplement 98 · standardAP
2000-09-20Manufacturing (CMC) · Supplement 97 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 96 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 95 · standardAP
1996-07-02Manufacturing (CMC) · Supplement 94 · standardAP
1995-07-21Manufacturing (CMC) · Supplement 89 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 92 · standardAP
1994-07-01Manufacturing (CMC) · Supplement 91 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 93 · standardAP
1993-06-14Manufacturing (CMC) · Supplement 85 · standardAP
1992-11-23Manufacturing (CMC) · Supplement 88 · standardAP
1992-06-12Manufacturing (CMC) · Supplement 84 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 86 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 82 · standardAP
1990-11-28Labeling · Supplement 83AP
1990-07-11Labeling · Supplement 81AP
1990-07-11Manufacturing (CMC) · Supplement 80 · standardAP
1989-10-16Labeling · Supplement 73AP
1989-10-16Manufacturing (CMC) · Supplement 72 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 79 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 78 · standardAP
1989-01-10Labeling · Supplement 77AP
1989-01-10Manufacturing (CMC) · Supplement 76 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 75 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 71 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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