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FDA NDA · NDA018876
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Sponsor: ICU MEDICAL INC
APPLICATION
NDA018876
TYPE
NDA
ORIGINAL APPROVAL
1986-01-17
LATEST ACTION
2013-09-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 74.5MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 74.5MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 298MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 298MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
Approval history
2013-09-05Manufacturing (CMC) · Supplement 45 · standardAP
2001-08-24Labeling · Supplement 24 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 23 · standardAP
1997-08-20Labeling · Supplement 20 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 21 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 16 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 15 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 19 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 18 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 17 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 13 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 12 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 9 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 10 · standardAP
1989-06-22Manufacturing (CMC) · Supplement 3 · standardAP
1988-03-28Labeling · Supplement 6AP
1988-03-28Manufacturing (CMC) · Supplement 5 · standardAP
1987-08-31Manufacturing (CMC) · Supplement 7 · standardAP
1986-10-09Manufacturing (CMC) · Supplement 1 · standardAP
1986-08-11Manufacturing (CMC) · Supplement 2 · standardAP
1986-01-17Type 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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