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FDA NDA · NDA018744
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA018744
TYPE
NDA
ORIGINAL APPROVAL
1982-11-09
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 9 · standardAP
1985-10-10Labeling · Supplement 5 · standardAP
1985-10-10Manufacturing (CMC) · Supplement 4 · standardAP
1985-09-05Manufacturing (CMC) · Supplement 3 · standardAP
1985-06-24Labeling · Supplement 7 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 6 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 2 · standardAP
1982-11-09Type 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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