Potassium Chloride

Treats potassium deficiency states. ANDA 80205, held by Hospira. Potassium Chloride.

As of Nov 15, 2026, ANDA 80205 (Potassium Chloride), held by Hospira, was first approved by FDA on Mar 16, 1972, with 30 approved supplements and 0 published complete response letters.

First approved: Mar 16, 1972
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Mar 16, 1972	Original application	Approved	None posted

Products

4 strengths and forms


Potassium Chloride2MEQ/ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride1MEQ/ML · injectable;injection	Potassium Chloride	Discontinued
Potassium Chloride2.4MEQ/ML · injectable;injection	Potassium Chloride	Discontinued
Potassium Chloride3.2MEQ/ML · injectable;injection	Potassium Chloride	Discontinued

All 31 submissions, including labeling and manufacturing supplements


Dec 2, 2022	Supplement 104Labeling · Standard review	Approved	None posted
Oct 4, 2007	Supplement 82Labeling	Approved	None posted
Oct 15, 2004	Supplement 71Labeling	Approved	None posted
Nov 7, 2002	Supplement 70Manufacturing	Approved	None posted
Oct 25, 2002	Supplement 69Manufacturing	Approved	None posted
Oct 22, 1996	Supplement 65Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 66Manufacturing	Approved	None posted
Sep 20, 1996	Supplement 63Manufacturing	Approved	None posted
Nov 10, 1994	Supplement 62Labeling	Approved	None posted
Aug 10, 1993	Supplement 61Labeling	Approved	None posted
Jun 2, 1992	Supplement 60Labeling	Approved	None posted
Mar 26, 1992	Supplement 59Labeling	Approved	None posted
Jan 24, 1992	Supplement 55Labeling	Approved	None posted
Nov 7, 1991	Supplement 58Labeling	Approved	None posted
Nov 7, 1991	Supplement 57Labeling	Approved	None posted
Feb 1, 1991	Supplement 56Labeling	Approved	None posted
Jul 20, 1989	Supplement 53Labeling	Approved	None posted
Jun 9, 1989	Supplement 52Labeling	Approved	None posted
Feb 25, 1986	Supplement 50Manufacturing	Approved	None posted
Aug 27, 1985	Supplement 49Manufacturing	Approved	None posted
Jun 12, 1985	Supplement 48Manufacturing	Approved	None posted
Jun 12, 1985	Supplement 47Manufacturing	Approved	None posted
Jun 12, 1985	Supplement 46Manufacturing	Approved	None posted
Jun 12, 1985	Supplement 43Manufacturing	Approved	None posted
Jun 12, 1985	Supplement 41Manufacturing	Approved	None posted
Jun 12, 1985	Supplement 40Manufacturing	Approved	None posted
Nov 21, 1984	Supplement 44Manufacturing	Approved	None posted
Feb 9, 1983	Supplement 34Manufacturing	Approved	None posted
Nov 2, 1982	Supplement 36Manufacturing	Approved	None posted
May 18, 1982	Supplement 32Manufacturing	Approved	None posted
Mar 16, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80205
Drugs@FDA: Overview at FDA
Company: Hospira

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