APPLICATION
NDA018238
TYPE
NDA
ORIGINAL APPROVAL
1980-10-17
LATEST ACTION
2018-04-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
MICRO-K · ReferenceDiscontinued
POTASSIUM CHLORIDE 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
MICRO-K 10 · ReferenceDiscontinued
POTASSIUM CHLORIDE 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2016-03-09Manufacturing (CMC) · Supplement 45 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 44 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 43 · standardAP
2014-06-12Manufacturing (CMC) · Supplement 42 · standardAP
2013-07-18Manufacturing (CMC) · Supplement 41 · standardAP
2013-03-25Manufacturing (CMC) · Supplement 40 · standardAP
2013-03-14Manufacturing (CMC) · Supplement 39 · standardAP
2000-07-10Manufacturing (CMC) · Supplement 28 · standardAP
2000-05-08Manufacturing (CMC) · Supplement 29 · standardAP
2000-03-09Manufacturing (CMC) · Supplement 27 · standardAP
1998-01-30Labeling · Supplement 23AP
1998-01-30Labeling · Supplement 22AP
1998-01-13Manufacturing (CMC) · Supplement 26 · standardAP
1993-08-19Manufacturing (CMC) · Supplement 25 · standardAP
1990-03-12Manufacturing (CMC) · Supplement 24 · standardAP
1988-06-30Manufacturing (CMC) · Supplement 21 · standardAP
1987-12-10Manufacturing (CMC) · Supplement 20 · standardAP
1987-06-26Manufacturing (CMC) · Supplement 19 · standardAP
1986-10-23Manufacturing (CMC) · Supplement 18 · standardAP
1986-02-14Manufacturing (CMC) · Supplement 17 · standardAP
1985-11-25Manufacturing (CMC) · Supplement 16 · standardAP
1985-08-08Manufacturing (CMC) · Supplement 14 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 12 · standardAP
1983-08-03Manufacturing (CMC) · Supplement 9 · standardAP
1983-05-04Manufacturing (CMC) · Supplement 10 · standardAP
1982-08-23REMS · Supplement 7 · standardAP
1982-03-08Manufacturing (CMC) · Supplement 4 · standardAP
1982-03-03Manufacturing (CMC) · Supplement 5 · standardAP
1982-03-03Manufacturing (CMC) · Supplement 6 · standardAP
1982-02-17Manufacturing (CMC) · Supplement 3 · standardAP
1981-06-02Manufacturing (CMC) · Supplement 2 · standardAP
1981-02-13Manufacturing (CMC) · Supplement 1 · standardAP
1980-10-17Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.