APPLICATION
NDA017850
TYPE
NDA
ORIGINAL APPROVAL
1980-05-22
LATEST ACTION
1995-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
KLOTRIXDiscontinued
POTASSIUM CHLORIDE 10MEQ · TABLET, EXTENDED RELEASE · ORAL
Approval history
1995-10-03Manufacturing (CMC) · Supplement 28 · standardAP
1990-10-03Manufacturing (CMC) · Supplement 27 · standardAP
1989-09-19Labeling · Supplement 26 · standardAP
1988-08-26Labeling · Supplement 23 · standardAP
1988-06-15Manufacturing (CMC) · Supplement 25 · standardAP
1988-06-07Manufacturing (CMC) · Supplement 24 · standardAP
1987-10-01Manufacturing (CMC) · Supplement 22 · standardAP
1987-05-15Manufacturing (CMC) · Supplement 21 · standardAP
1987-03-11Manufacturing (CMC) · Supplement 19 · standardAP
1987-02-13Manufacturing (CMC) · Supplement 20 · standardAP
1985-10-24Manufacturing (CMC) · Supplement 17 · standardAP
1985-10-24Manufacturing (CMC) · Supplement 18 · standardAP
1985-07-30Manufacturing (CMC) · Supplement 15 · standardAP
1985-06-14Manufacturing (CMC) · Supplement 13 · standardAP
1985-05-24Manufacturing (CMC) · Supplement 16 · standardAP
1985-05-15Manufacturing (CMC) · Supplement 14 · standardAP
1984-08-13Labeling · Supplement 4 · standardAP
1983-06-09Manufacturing (CMC) · Supplement 12 · standardAP
1983-06-09Manufacturing (CMC) · Supplement 11 · standardAP
1983-05-04Manufacturing (CMC) · Supplement 10 · standardAP
1983-05-04Manufacturing (CMC) · Supplement 9 · standardAP
1983-05-04Manufacturing (CMC) · Supplement 8 · standardAP
1983-01-04Manufacturing (CMC) · Supplement 7 · standardAP
1982-02-04Manufacturing (CMC) · Supplement 6 · standardAP
1981-10-01Labeling · Supplement 5 · standardAP
1981-03-17Manufacturing (CMC) · Supplement 3 · standardAP
1980-08-14Manufacturing (CMC) · Supplement 1 · standardAP
1980-08-14Manufacturing (CMC) · Supplement 2 · standardAP
1980-05-22Type 5 - New Formulation or New Manufacturer · Original · 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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