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FDA NDA · NDA018268
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%
Sponsor: B BRAUN
APPLICATION
NDA018268
TYPE
NDA
ORIGINAL APPROVAL
1980-09-05
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%Discontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%Discontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 18 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 10 · standardAP
1986-01-18Labeling · Supplement 14 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 13 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 11 · standardAP
1985-06-27Labeling · Supplement 16 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 15 · standardAP
1984-09-19Labeling · Supplement 12 · standardAP
1981-10-29Labeling · Supplement 2 · standardAP
1981-10-26Manufacturing (CMC) · Supplement 7 · standardAP
1981-01-02Manufacturing (CMC) · Supplement 4 · standardAP
1980-12-30Manufacturing (CMC) · Supplement 6 · standardAP
1980-12-12Manufacturing (CMC) · Supplement 3 · standardAP
1980-12-10Manufacturing (CMC) · Supplement 5 · standardAP
1980-10-29Manufacturing (CMC) · Supplement 1 · standardAP
1980-09-05Type 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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