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FDA NDA · NDA019708

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

sodium chloride and potassium chloride

Sponsor: B BRAUN

APPLICATION
NDA019708
TYPE
NDA
ORIGINAL APPROVAL
1989-09-29
LATEST ACTION
2026-01-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
POTASSIUM CHLORIDE 220MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
POTASSIUM CHLORIDE 110MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
POTASSIUM CHLORIDE 37MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION

Approval history

2026-01-17Labeling · Supplement 40 · standard — Letter ↗AP
2014-08-22Manufacturing (CMC) · Supplement 22 · standardAP
2005-08-31Labeling · Supplement 16 · standard — Letter ↗AP
2004-09-27Labeling · Supplement 13 · standard — Label ↗AP
2002-07-23Manufacturing (CMC) · Supplement 12 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 10 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 9 · standardAP
1999-05-04Manufacturing (CMC) · Supplement 8 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 7 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 6 · standardAP
1992-12-29Manufacturing (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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