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FDA NDA · NDA019367

POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE

dextrose monohydrate, sodium chloride, sodium lactate, potassium chloride, calcium chloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA019367
TYPE
NDA
ORIGINAL APPROVAL
1985-04-05
LATEST ACTION
2025-11-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 328MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 254MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 179MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 105MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 254MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 328MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 179MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 105MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION

Approval history

2025-11-05Labeling · Supplement 42 · standard — Letter ↗AP
2019-10-09Labeling · Supplement 36 · standard — Letter ↗AP
2017-12-06Labeling · Supplement 30 · standard — Label ↗AP
2014-09-30Manufacturing (CMC) · Supplement 31 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 29 · standardAP
2011-10-19Labeling · Supplement 26 · unknown — Label ↗AP
2005-08-26Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2005-06-07Labeling · Supplement 21 · standard — Label ↗AP
2003-01-03Labeling · Supplement 15 · standard — Letter ↗AP
2001-08-14Manufacturing (CMC) · Supplement 16 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 14 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 13 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 11 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 12 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 10 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 8 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 7 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 6 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 5 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 3 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 2 · standardAP
1985-04-05Type 5 - New Formulation or New Manufacturer · Original · standardAP
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