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FDA NDA · NDA018008

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE

potassium chloride, dextrose monohydrate and sodium chloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA018008
TYPE
NDA
ORIGINAL APPROVAL
1979-02-02
LATEST ACTION
2019-02-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ 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 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 40MEQ 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 20MEQ 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 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION

Approval history

2019-02-21Labeling · Supplement 73 · standard — Label ↗AP
2014-09-26Manufacturing (CMC) · Supplement 71 · standardAP
2013-09-10Labeling · Supplement 70 · standard — Letter ↗AP
2007-04-20Labeling · Supplement 66 · standard — Letter ↗AP
2005-08-26Manufacturing (CMC) · Supplement 65 · standard — Label ↗AP
2004-06-02Labeling · Supplement 63 · standard — Letter ↗AP
2003-04-14Labeling · Supplement 59 · standard — Letter ↗AP
2001-08-14Manufacturing (CMC) · Supplement 60 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 58 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 57 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 55 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 56 · standardAP
1993-04-22Labeling · Supplement 54 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 53 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 51 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 50 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 49 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 48 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 47 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 46 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 44 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 37 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 36 · standardAP
1985-07-03Labeling · Supplement 42AP
1985-06-13Manufacturing (CMC) · Supplement 41 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 43 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 34 · standardAP
1984-10-23Manufacturing (CMC) · Supplement 40 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 35 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 39 · standardAP
1983-07-11Labeling · Supplement 29AP
1982-06-03Manufacturing (CMC) · Supplement 26 · standardAP
1982-05-25Labeling · Supplement 32AP
1982-04-28Labeling · Supplement 31AP
1982-04-16Manufacturing (CMC) · Supplement 24 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 22 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 28 · standardAP
1981-11-09Manufacturing (CMC) · Supplement 25 · standardAP
1981-08-26Labeling · Supplement 23AP
1981-06-29Manufacturing (CMC) · Supplement 20 · standardAP
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