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FDA NDA · NDA019699

POTASSIUM CHLORIDE IN DEXTROSE

dextrose and potassium chloride

Sponsor: B BRAUN

APPLICATION
NDA019699
TYPE
NDA
ORIGINAL APPROVAL
1989-09-29
LATEST ACTION
2020-07-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 220MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 37MG/100ML · INJECTABLE · INJECTION

Approval history

2020-07-10Labeling · Supplement 33 · standard — Letter ↗AP
2014-08-22Manufacturing (CMC) · Supplement 21 · standardAP
2004-09-27Labeling · Supplement 13 · standard — Letter ↗AP
2002-07-23Manufacturing (CMC) · Supplement 12 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 10 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 9 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 8 · standardAP
1999-05-04Manufacturing (CMC) · Supplement 7 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 6 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 5 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 3 · standardAP
1990-09-21Manufacturing (CMC) · Supplement 2 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 1 · standardAP
1989-09-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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