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FDA NDA · NDA020163

DIANEAL PD-2 WITH DEXTROSE

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

Sponsor: VANTIVE US HLTHCARE

APPLICATION
NDA020163
TYPE
NDA
ORIGINAL APPROVAL
1992-12-04
LATEST ACTION
2023-06-05
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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 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-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

Approval history

2023-06-05Labeling · Supplement 30 · standard — Letter ↗AP
2016-08-16Labeling · Supplement 28 · standard — Label ↗AP
2015-09-01Labeling · Supplement 27 · standard — Letter ↗AP
2015-06-05Manufacturing (CMC) · Supplement 26 · standardAP
2015-02-09Labeling · Supplement 25 · standard — Label ↗AP
2014-09-30Manufacturing (CMC) · Supplement 24 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 23 · standardAP
2013-04-19Labeling · Supplement 20 · standard — Letter ↗AP
2005-08-09Labeling · Supplement 12 · standard — Letter ↗AP
2005-08-09Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 8 · standardAP
2001-08-22Manufacturing (CMC) · Supplement 7 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 6 · standardAP
1996-11-22Manufacturing (CMC) · Supplement 5 · standardAP
1995-02-09Manufacturing (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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