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FDA NDA · NDA018371
POTASSIUM CHLORIDE IN DEXTROSE
dextrose monohydrate and potassium chloride injection, solution
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA018371
TYPE
NDA
ORIGINAL APPROVAL
1980-05-29
LATEST ACTION
2014-09-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 149MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 298MG/100ML · INJECTABLE · INJECTION
Approval history
2014-09-08Manufacturing (CMC) · Supplement 91 · standardAP
2001-07-27Manufacturing (CMC) · Supplement 73 · standardAP
1999-08-27Labeling · Supplement 65AP
1999-05-26Labeling · Supplement 72AP
1999-02-01Manufacturing (CMC) · Supplement 70 · standardAP
1999-01-05Labeling · Supplement 71AP
1998-12-01Manufacturing (CMC) · Supplement 69 · standardAP
1997-08-22Labeling · Supplement 67AP
1997-06-11Manufacturing (CMC) · Supplement 68 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 62 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 61 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 66 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 64 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 63 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 57 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 56 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 58 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 51 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 52 · standardAP
1989-06-22Manufacturing (CMC) · Supplement 27 · standardAP
1988-05-25Labeling · Supplement 49AP
1988-05-25Manufacturing (CMC) · Supplement 48 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 46 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 45 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 44 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 42 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 30 · standardAP
1985-11-29Labeling · Supplement 31AP
1985-10-29Manufacturing (CMC) · Supplement 29 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 38 · standardAP
1985-10-26Labeling · Supplement 40AP
1985-09-26Manufacturing (CMC) · Supplement 33 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 43 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 39 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 28 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 37 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 34 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 25 · standardAP
1984-10-10Manufacturing (CMC) · Supplement 18 · standardAP
1984-10-10Labeling · Supplement 19AP
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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