APPLICATION
ANDA080205
TYPE
ANDA
ORIGINAL APPROVAL
1972-03-16
LATEST ACTION
2022-12-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
POTASSIUM CHLORIDEDiscontinued
POTASSIUM CHLORIDE 2.4MEQ/ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDEDiscontinued
POTASSIUM CHLORIDE 3.2MEQ/ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDEDiscontinued
POTASSIUM CHLORIDE 1MEQ/ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE · ReferencePrescription
POTASSIUM CHLORIDE 2MEQ/ML · INJECTABLE · INJECTION
Approval history
2022-12-02Labeling · Supplement 104 · standardAP
2007-10-04Labeling · Supplement 82AP
2004-10-15Labeling · Supplement 71AP
2002-11-07Manufacturing (CMC) · Supplement 70AP
2002-10-25Manufacturing (CMC) · Supplement 69AP
1996-10-22Manufacturing (CMC) · Supplement 65AP
1996-10-03Manufacturing (CMC) · Supplement 66AP
1996-09-20Manufacturing (CMC) · Supplement 63AP
1994-11-10Labeling · Supplement 62AP
1993-08-10Labeling · Supplement 61AP
1992-06-02Labeling · Supplement 60AP
1992-03-26Labeling · Supplement 59AP
1992-01-24Labeling · Supplement 55AP
1991-11-07Labeling · Supplement 58AP
1991-11-07Labeling · Supplement 57AP
1991-02-01Labeling · Supplement 56AP
1989-07-20Labeling · Supplement 53AP
1989-06-09Labeling · Supplement 52AP
1986-02-25Manufacturing (CMC) · Supplement 50AP
1985-08-27Manufacturing (CMC) · Supplement 49AP
1985-06-12Manufacturing (CMC) · Supplement 43AP
1985-06-12Manufacturing (CMC) · Supplement 41AP
1985-06-12Manufacturing (CMC) · Supplement 48AP
1985-06-12Manufacturing (CMC) · Supplement 46AP
1985-06-12Manufacturing (CMC) · Supplement 40AP
1985-06-12Manufacturing (CMC) · Supplement 47AP
1984-11-21Manufacturing (CMC) · Supplement 44AP
1983-02-09Manufacturing (CMC) · Supplement 34AP
1982-11-02Manufacturing (CMC) · Supplement 36AP
1982-05-18Manufacturing (CMC) · Supplement 32AP
1972-03-16OriginalAP
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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