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FDA NDA · NDA019630

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE

dextrose, sodium chloride, and potassium chloride

Sponsor: B BRAUN

APPLICATION
NDA019630
TYPE
NDA
ORIGINAL APPROVAL
1988-02-17
LATEST ACTION
2023-06-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPrescription
DEXTROSE 3.3GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPrescription
DEXTROSE 3.3GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPrescription
DEXTROSE 3.3GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPrescription
DEXTROSE 3.3GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPrescription
DEXTROSE 3.3GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION

Approval history

2023-06-27Labeling · Supplement 53 · standard — Letter ↗AP
2014-08-22Manufacturing (CMC) · Supplement 32 · standardAP
2013-05-30Manufacturing (CMC) · Supplement 37 · standardAP
2013-05-22Manufacturing (CMC) · Supplement 38 · standardAP
2005-08-31Labeling · Supplement 26 · standard — Letter ↗AP
2004-09-27Labeling · Supplement 23 · standard — Label ↗AP
2002-07-23Manufacturing (CMC) · Supplement 22 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 20 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 19 · standardAP
1999-05-04Manufacturing (CMC) · Supplement 18 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 17 · standardAP
1995-01-13Manufacturing (CMC) · Supplement 16 · standardAP
1994-12-21Manufacturing (CMC) · Supplement 15 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 14 · standardAP
1992-12-29Manufacturing (CMC) · Supplement 13 · standardAP
1992-05-07Labeling · Supplement 9AP
1992-05-07Manufacturing (CMC) · Supplement 8 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 10 · standardAP
1990-04-13Manufacturing (CMC) · Supplement 7 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 4 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 6 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 5 · standardAP
1988-12-21Manufacturing (CMC) · Supplement 3 · standardAP
1988-08-25Manufacturing (CMC) · Supplement 2 · standardAP
1988-03-24Labeling · Supplement 1AP
1988-02-17Type 5 - New Formulation or New Manufacturer · Original · standardAP
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