APPLICATION
NDA019439
TYPE
NDA
ORIGINAL APPROVAL
1986-06-13
LATEST ACTION
2008-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
POTASSIUM CHLORIDE · ReferenceDiscontinued
POTASSIUM CHLORIDE 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
POTASSIUM CHLORIDE · ReferenceDiscontinued
POTASSIUM CHLORIDE 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-02-21Manufacturing (CMC) · Supplement 21 · standardAP
2000-09-01Manufacturing (CMC) · Supplement 20 · standardAP
1997-03-21Manufacturing (CMC) · Supplement 19 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 18 · standardAP
1993-11-08Manufacturing (CMC) · Supplement 17 · standardAP
1990-12-20Labeling · Supplement 15 · standardAP
1990-08-03Manufacturing (CMC) · Supplement 11 · standardAP
1989-08-08Labeling · Supplement 14 · standardAP
1989-04-04Manufacturing (CMC) · Supplement 10 · standardAP
1989-03-15Manufacturing (CMC) · Supplement 9 · standardAP
1989-03-15Manufacturing (CMC) · Supplement 12 · standardAP
1988-10-26Manufacturing (CMC) · Supplement 8 · standardAP
1988-10-04Manufacturing (CMC) · Supplement 7 · standardAP
1988-08-23Labeling · Supplement 3 · standardAP
1988-08-23Labeling · Supplement 1 · standardAP
1988-06-02Manufacturing (CMC) · Supplement 5 · standardAP
1988-05-05Manufacturing (CMC) · Supplement 4 · standardAP
1987-08-12Labeling · Supplement 2 · standardAP
1986-06-13Type 3 - New Dosage Form · 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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