APPLICATION
ANDA083163
TYPE
ANDA
ORIGINAL APPROVAL
1975-08-29
LATEST ACTION
2023-03-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
POTASSIUM CHLORIDEDiscontinued
POTASSIUM CHLORIDE 2MEQ/ML · INJECTABLE · INJECTION
Approval history
2023-03-21Labeling · Supplement 27 · standardAP
2022-12-02Labeling · Supplement 26 · standardAP
1998-01-14Manufacturing (CMC) · Supplement 20AP
1996-06-18Manufacturing (CMC) · Supplement 22AP
1996-06-18Manufacturing (CMC) · Supplement 25AP
1996-06-18Labeling · Supplement 23AP
1995-09-19Manufacturing (CMC) · Supplement 24AP
1994-06-17Manufacturing (CMC) · Supplement 21AP
1993-10-29Manufacturing (CMC) · Supplement 19AP
1993-08-27Manufacturing (CMC) · Supplement 18AP
1993-02-03Manufacturing (CMC) · Supplement 17AP
1992-06-15Labeling · Supplement 15AP
1992-03-26Labeling · Supplement 16AP
1991-04-04Labeling · Supplement 14AP
1991-02-07Manufacturing (CMC) · Supplement 10AP
1991-02-07Manufacturing (CMC) · Supplement 11AP
1987-03-12Manufacturing (CMC) · Supplement 6AP
1987-02-05Manufacturing (CMC) · Supplement 8AP
1987-02-05Manufacturing (CMC) · Supplement 9AP
1975-08-29OriginalAP
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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