Potassium Chloride

NDA 19439, held by Schering. Potassium Chloride.

As of Nov 13, 2026, NDA 19439 (Potassium Chloride), held by Schering, was first approved by FDA on Jun 13, 1986, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1986
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jun 13, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Potassium Chloride20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Potassium Chloride	DiscontinuedReference drug
Potassium Chloride10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Potassium Chloride	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Jun 13, 2008	Supplement 22Labeling · Standard review	Approved	Label Letter
Feb 21, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 1, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 21, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 15, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 8, 1993	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 20, 1990	Supplement 15Labeling · Standard review	Approved	None posted
Aug 3, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 8, 1989	Supplement 14Labeling · Standard review	Approved	None posted
Apr 4, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 15, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 15, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 26, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 4, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 23, 1988	Supplement 3Labeling · Standard review	Approved	None posted
Aug 23, 1988	Supplement 1Labeling · Standard review	Approved	None posted
Jun 2, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
May 5, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 12, 1987	Supplement 2Labeling · Standard review	Approved	None posted
Jun 13, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19439
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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