← FDA DRUG APPROVALS

FDA NDA · NDA020183

DIANEAL LOW CALCIUM WITH DEXTROSE

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

Sponsor: VANTIVE US HLTHCARE

APPLICATION
NDA020183
TYPE
NDA
ORIGINAL APPROVAL
1992-12-04
LATEST ACTION
2023-06-05
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 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 LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER · ReferenceDiscontinued
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 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

Approval history

2023-06-05Labeling · Supplement 29 · standard — Letter ↗AP
2016-08-16Labeling · Supplement 27 · standard — Label ↗AP
2015-09-01Labeling · Supplement 26 · standard — Label ↗AP
2015-02-09Labeling · Supplement 24 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 23 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 22 · standardAP
2013-04-19Labeling · Supplement 19 · standard — Label ↗AP
2007-08-23Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
2005-08-09Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2005-08-09Labeling · Supplement 11 · standard — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 7 · standardAP
2001-08-22Manufacturing (CMC) · Supplement 6 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 5 · standardAP
1996-11-22Manufacturing (CMC) · Supplement 4 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 1 · standardAP
1994-06-01Manufacturing (CMC) · Supplement 3 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 2 · standardAP
1992-12-04Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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