Micro-K, Micro-K 10

NDA 18238, held by Nesher Pharms. Potassium Chloride.

As of Nov 13, 2026, NDA 18238 (Micro-K, Micro-K 10), held by Nesher Pharms, was first approved by FDA on Oct 17, 1980, with 36 approved supplements and 0 published complete response letters.

First approved: Oct 17, 1980
Review: Standard
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below


May 14, 1984	Supplement 11Efficacy (new indication or use)	Approved	Review
Oct 17, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Micro-K8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Potassium Chloride	DiscontinuedReference drug
Micro-K 1010MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Potassium Chloride	DiscontinuedReference drug

All 37 submissions, including labeling and manufacturing supplements


Apr 30, 2018	Supplement 46Labeling · Standard review	Approved	Letter Label
Mar 9, 2016	Supplement 45Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 44Manufacturing · Standard review	Approved	None posted
Nov 26, 2014	Supplement 43Manufacturing · Standard review	Approved	None posted
Jun 12, 2014	Supplement 42Manufacturing · Standard review	Approved	None posted
Jul 18, 2013	Supplement 41Manufacturing · Standard review	Approved	None posted
Mar 25, 2013	Supplement 40Manufacturing · Standard review	Approved	None posted
Mar 14, 2013	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 20, 2003	Supplement 31Labeling · Standard review	Approved	Letter
Jul 10, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
May 8, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 9, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 30, 1998	Supplement 23Labeling	Approved	None posted
Jan 30, 1998	Supplement 22Labeling	Approved	None posted
Jan 13, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 19, 1993	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 12, 1990	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 30, 1988	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 10, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 26, 1987	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 23, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 14, 1986	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 25, 1985	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 8, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 25, 1985	Supplement 13Manufacturing · Standard review	Approved	Review
May 14, 1984	Supplement 11Efficacy (new indication or use)	Approved	Review
Mar 16, 1984	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 3, 1983	Supplement 9Manufacturing · Standard review	Approved	None posted
May 4, 1983	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 23, 1982	Supplement 7REMS · Standard review	Approved	None posted
Mar 8, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 3, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 3, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 17, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 2, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 13, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 17, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18238
Drugs@FDA: Overview at FDA
Company: Nesher Pharmaceuticals

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