K-Tab

NDA 18279, held by Abbvie. Potassium Chloride.

As of Nov 14, 2026, NDA 18279 (K-Tab), held by Abbvie, was first approved by FDA on Jun 9, 1980, with 31 approved supplements and 0 published complete response letters.

First approved: Jun 9, 1980
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Jun 9, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


K-Tab10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Potassium Chloride	DiscontinuedReference drug
K-Tab8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Potassium Chloride	DiscontinuedReference drug
K-Tab20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Potassium Chloride	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Apr 30, 2018	Supplement 37Labeling · Standard review	Approved	Label Letter
Sep 30, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 26, 2014	Supplement 34Manufacturing · Standard review	Approved	Label
Jun 3, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 25, 2013	Supplement 33Manufacturing · Standard review	Approved	Label
Aug 1, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 15, 2012	Supplement 29Labeling	Approved	Letter
Dec 14, 2004	Supplement 27Labeling · Standard review	Approved	Letter
Dec 24, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 2, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 16, 1998	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 29, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 21, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 27, 1993	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 26, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 2, 1989	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 1, 1988	Supplement 16Labeling	Approved	None posted
Aug 1, 1988	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 12, 1987	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 7, 1986	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 17, 1986	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 14, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 25, 1985	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 13, 1984	Supplement 8Labeling	Approved	None posted
Aug 1, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 10, 1982	Supplement 5Labeling	Approved	None posted
Jul 2, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 29, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 4, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 3, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 16, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 9, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18279
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters