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FDA NDA · NDA018460
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA018460
TYPE
NDA
ORIGINAL APPROVAL
1981-10-29
LATEST ACTION
2002-04-05
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 26MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 15MG/100ML, SODIUM CHLORIDE 560MG/100ML, SODIUM LACTATE 390MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 26MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 15MG/100ML, SODIUM CHLORIDE 560MG/100ML, SODIUM LACTATE 390MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 26MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 5MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM LACTATE 450MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 26MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 5MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM LACTATE 450MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 26MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 5MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM LACTATE 450MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 15MG/100ML, SODIUM ACETATE 610MG/100ML, SODIUM CHLORIDE 560MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 15MG/100ML, SODIUM ACETATE 610MG/100ML, SODIUM CHLORIDE 560MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 26MG/100ML, DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 5MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM LACTATE 450MG/100ML · SOLUTION · INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 15MG/100ML, SODIUM ACETATE 610MG/100ML, SODIUM CHLORIDE 560MG/100ML · SOLUTION · INTRAPERITONEAL
Approval history
2002-04-05Manufacturing (CMC) · Supplement 30 · standardAP
2000-05-03Manufacturing (CMC) · Supplement 29 · standardAP
1998-02-09Manufacturing (CMC) · Supplement 28 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 27 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 26 · standardAP
1991-11-05Labeling · Supplement 24AP
1990-09-11Manufacturing (CMC) · Supplement 23 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 20 · standardAP
1988-01-13Labeling · Supplement 21AP
1987-07-09Labeling · Supplement 19AP
1987-03-05Manufacturing (CMC) · Supplement 16 · standardAP
1986-10-10Manufacturing (CMC) · Supplement 17 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 9 · standardAP
1986-01-31Labeling · Supplement 10AP
1986-01-29Labeling · Supplement 14AP
1986-01-29Manufacturing (CMC) · Supplement 13 · standardAP
1985-05-24Manufacturing (CMC) · Supplement 8 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 11 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 12 · standardAP
1984-09-08Labeling · Supplement 5AP
1983-11-02Labeling · Supplement 7AP
1983-11-02Manufacturing (CMC) · Supplement 6 · standardAP
1983-02-16Manufacturing (CMC) · Supplement 3 · standardAP
1983-02-16Labeling · Supplement 4AP
1982-05-26Manufacturing (CMC) · Supplement 1 · standardAP
1982-01-25Manufacturing (CMC) · Supplement 2 · standardAP
1981-10-29Type 3 - New Dosage Form · 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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