← FDA DRUG APPROVALS
FDA NDA · NDA019691
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE
dextrose monohydrate, sodium chloride, and potassium chloride
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA019691
TYPE
NDA
ORIGINAL APPROVAL
1988-03-24
LATEST ACTION
2014-09-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 298MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 74.5MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 298MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 74.5MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2014-09-08Manufacturing (CMC) · Supplement 34 · standardAP
2002-07-18Labeling · Supplement 16AP
1999-05-19Labeling · Supplement 14AP
1998-12-01Manufacturing (CMC) · Supplement 15 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 13 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 8 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 7 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 12 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 11 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 10 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 9 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 5 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 4 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 1 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 2 · standardAP
1988-03-24Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.