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FDA NDA · NDA017648
POTASSIUM CHLORIDE IN SODIUM CHLORIDE
potassium chloride and sodium chloride
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA017648
TYPE
NDA
ORIGINAL APPROVAL
1979-02-02
LATEST ACTION
2019-01-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%Discontinued
POTASSIUM CHLORIDE 75MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% · ReferencePrescription
POTASSIUM CHLORIDE 300MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% · ReferencePrescription
POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
POTASSIUM CHLORIDE 224MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% · ReferencePrescription
POTASSIUM CHLORIDE 150MG/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2016-11-17Manufacturing (CMC) · Supplement 70 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 69 · standardAP
2002-11-26Manufacturing (CMC) · Supplement 61 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 59 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 57 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 56 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 54 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 55 · 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
1989-01-12Manufacturing (CMC) · Supplement 47 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 46 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 45 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 43 · standardAP
1985-10-04Manufacturing (CMC) · Supplement 41 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 35 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 36 · standardAP
1985-06-26Labeling · Supplement 40AP
1985-06-13Manufacturing (CMC) · Supplement 39 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 42 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 33 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 34 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 38 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 25 · standardAP
1982-05-25Labeling · Supplement 31AP
1982-04-16Manufacturing (CMC) · Supplement 23 · standardAP
1982-04-12Labeling · Supplement 30AP
1981-12-21Manufacturing (CMC) · Supplement 21 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 27 · standardAP
1981-11-09Manufacturing (CMC) · Supplement 24 · standardAP
1981-08-26Labeling · Supplement 22AP
1981-06-29Manufacturing (CMC) · Supplement 19 · standardAP
1981-05-29Manufacturing (CMC) · Supplement 18 · standardAP
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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