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FDA NDA · NDA019308

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE

potassium chloride, dextrose monohydrate and sodium chloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA019308
TYPE
NDA
ORIGINAL APPROVAL
1985-04-05
LATEST ACTION
2019-02-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
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 CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ 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 40MEQ 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 20MEQ 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 20MEQ 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 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION

Approval history

2019-02-21Labeling · Supplement 30 · standard — Letter ↗AP
2013-09-10Labeling · Supplement 27 · standard — Letter ↗AP
2007-04-20Labeling · Supplement 23 · standard — Letter ↗AP
2005-08-26Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2004-06-02Labeling · Supplement 20 · standard — Letter ↗AP
2003-04-14Labeling · Supplement 17 · standard — Letter ↗AP
2001-08-14Manufacturing (CMC) · Supplement 18 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 16 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 15 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 13 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 14 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 12 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 10 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 9 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 8 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 7 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 6 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 4 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 3 · standardAP
1985-04-05Type 5 - New Formulation or New Manufacturer · Original · standardAP
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