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FDA NDA · NDA018629
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE
potassium chloride, dextrose monohydrate and sodium chloride
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA018629
TYPE
NDA
ORIGINAL APPROVAL
1982-03-23
LATEST ACTION
2019-02-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
Approval history
2006-07-10Labeling · Supplement 39AP
2004-03-15Labeling · Supplement 34AP
2001-08-29Manufacturing (CMC) · Supplement 31 · standardAP
2001-02-28Labeling · Supplement 30AP
2000-01-28Manufacturing (CMC) · Supplement 29 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 28 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 26 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 27 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 25 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 23 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 22 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 21 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 20 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 19 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 17 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 16 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 14 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 6 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 5 · standardAP
1985-07-03Labeling · Supplement 13AP
1985-06-13Manufacturing (CMC) · Supplement 12 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 7 · standardAP
1984-10-23Manufacturing (CMC) · Supplement 11 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 4 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 10 · standardAP
1983-07-11Labeling · Supplement 9AP
1982-05-25Labeling · Supplement 2AP
1982-05-07Labeling · Supplement 1AP
1982-03-23Type 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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