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FDA NDA · NDA018807
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA018807
TYPE
NDA
ORIGINAL APPROVAL
1983-08-26
LATEST ACTION
2002-04-05
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 510MG/100ML, DEXTROSE 50GM/100ML, MAGNESIUM CHLORIDE 200MG/100ML, SODIUM ACETATE 9.4GM/100ML, SODIUM CHLORIDE 11GM/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 510MG/100ML, DEXTROSE 50GM/100ML, MAGNESIUM CHLORIDE 200MG/100ML, SODIUM ACETATE 9.2GM/100ML, SODIUM CHLORIDE 9.6GM/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 510MG/100ML, DEXTROSE 30GM/100ML, MAGNESIUM CHLORIDE 200MG/100ML, SODIUM ACETATE 9.4GM/100ML, SODIUM CHLORIDE 11GM/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 510MG/100ML, DEXTROSE 30GM/100ML, MAGNESIUM CHLORIDE 200MG/100ML, SODIUM ACETATE 9.2GM/100ML, SODIUM CHLORIDE 9.6GM/100ML · SOLUTION · INTRAPERITONEAL
Approval history
2002-04-05Manufacturing (CMC) · Supplement 14 · standardAP
1998-02-09Manufacturing (CMC) · Supplement 13 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 12 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 11 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 9 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 6 · standardAP
1988-04-12Labeling · Supplement 7AP
1987-03-05Manufacturing (CMC) · Supplement 2 · standardAP
1986-10-10Manufacturing (CMC) · Supplement 4 · standardAP
1986-08-27Manufacturing (CMC) · Supplement 3 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 1 · standardAP
1983-08-26Type 5 - New Formulation or New Manufacturer · Original · 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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