Potassium Chloride

ANDA 87585, held by Luitpold. Potassium Chloride.

As of Nov 15, 2026, ANDA 87585 (Potassium Chloride), held by Luitpold, was first approved by FDA on Jun 30, 1981, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1981
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 30, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride2MEQ/ML · injectable;injection	Potassium Chloride	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Nov 7, 1997	Supplement 23Manufacturing	Approved	None posted
Mar 6, 1996	Supplement 22Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 21Manufacturing	Approved	None posted
Jun 11, 1993	Supplement 20Manufacturing	Approved	None posted
Jun 11, 1993	Supplement 19Labeling	Approved	None posted
Nov 22, 1991	Supplement 18Labeling	Approved	None posted
Jul 29, 1991	Supplement 16Manufacturing	Approved	None posted
Mar 27, 1991	Supplement 14Manufacturing	Approved	None posted
Feb 4, 1991	Supplement 17Labeling	Approved	None posted
May 18, 1989	Supplement 15Manufacturing	Approved	None posted
Nov 3, 1988	Supplement 13Labeling	Approved	None posted
Jan 13, 1986	Supplement 11Manufacturing	Approved	None posted
Jan 13, 1986	Supplement 10Manufacturing	Approved	None posted
Jul 19, 1984	Supplement 6Manufacturing	Approved	None posted
Jul 19, 1984	Supplement 5Manufacturing	Approved	None posted
Jul 13, 1983	Supplement 4Manufacturing	Approved	None posted
Sep 22, 1982	Supplement 1Manufacturing	Approved	None posted
Sep 16, 1982	Supplement 2Manufacturing	Approved	None posted
Jun 30, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87585
Drugs@FDA: Overview at FDA
Company: Luitpold 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