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FDA NDA · NDA018279

K-TAB

Sponsor: ABBVIE

APPLICATION
NDA018279
TYPE
NDA
ORIGINAL APPROVAL
1980-06-09
LATEST ACTION
2018-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

K-TAB · ReferenceDiscontinued
POTASSIUM CHLORIDE 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
K-TAB · ReferenceDiscontinued
POTASSIUM CHLORIDE 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
K-TAB · ReferenceDiscontinued
POTASSIUM CHLORIDE 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-04-30Labeling · Supplement 37 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 30 · standardAP
2014-06-26Manufacturing (CMC) · Supplement 34 · standard — Label ↗AP
2014-06-03Manufacturing (CMC) · Supplement 32 · standardAP
2013-11-25Manufacturing (CMC) · Supplement 33 · standard — Label ↗AP
2013-08-01Manufacturing (CMC) · Supplement 31 · standardAP
2012-02-15Labeling · Supplement 29 · unknown — Letter ↗AP
2004-12-14Labeling · Supplement 27 · standard — Letter ↗AP
2002-12-24Manufacturing (CMC) · Supplement 25 · standardAP
2002-10-02Manufacturing (CMC) · Supplement 24 · standardAP
1998-04-16Manufacturing (CMC) · Supplement 23 · standardAP
1997-10-29Manufacturing (CMC) · Supplement 22 · standardAP
1996-11-21Manufacturing (CMC) · Supplement 21 · standardAP
1993-01-27Manufacturing (CMC) · Supplement 20 · standardAP
1990-03-26Manufacturing (CMC) · Supplement 19 · standardAP
1989-11-02Manufacturing (CMC) · Supplement 17 · standardAP
1988-08-01Manufacturing (CMC) · Supplement 15 · standardAP
1988-08-01Labeling · Supplement 16AP
1987-06-12Manufacturing (CMC) · Supplement 14 · standardAP
1986-10-07Manufacturing (CMC) · Supplement 11 · standardAP
1986-06-17Manufacturing (CMC) · Supplement 12 · standardAP
1986-01-14Manufacturing (CMC) · Supplement 10 · standardAP
1985-03-25Manufacturing (CMC) · Supplement 9 · standardAP
1984-08-13Labeling · Supplement 8AP
1984-08-01Manufacturing (CMC) · Supplement 7 · standardAP
1982-11-10Labeling · Supplement 5AP
1982-07-02Manufacturing (CMC) · Supplement 6 · standardAP
1981-04-29Manufacturing (CMC) · Supplement 4 · standardAP
1981-02-04Manufacturing (CMC) · Supplement 1 · standardAP
1981-02-03Manufacturing (CMC) · Supplement 2 · standardAP
1981-01-16Manufacturing (CMC) · Supplement 3 · standardAP
1980-06-09Type 3 - New Dosage Form · Original · standardAP
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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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