Potassium Chloride

Treats potassium deficiency states. ANDA 85870, held by B Braun. Potassium Chloride.

As of Nov 15, 2026, ANDA 85870 (Potassium Chloride), held by B Braun, was first approved by FDA on Mar 21, 1978, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 21, 1978
Supplements approved: 13
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. This is a concentrated solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 21, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Dec 6, 2022	Supplement 38Labeling · Standard review	Approved	None posted
Dec 2, 2022	Supplement 39Labeling · Standard review	Approved	None posted
Mar 19, 2004	Supplement 20Labeling	Approved	None posted
Oct 7, 2002	Supplement 18Manufacturing	Approved	None posted
Jul 24, 1998	Supplement 16Manufacturing	Approved	None posted
Feb 5, 1992	Supplement 15Labeling	Approved	None posted
Feb 22, 1990	Supplement 14Labeling	Approved	None posted
Jul 22, 1983	Supplement 10Manufacturing	Approved	None posted
Jul 22, 1983	Supplement 8Manufacturing	Approved	None posted
Sep 23, 1982	Supplement 6Manufacturing	Approved	None posted
Sep 23, 1982	Supplement 5Manufacturing	Approved	None posted
Sep 23, 1982	Supplement 4Manufacturing	Approved	None posted
Sep 23, 1982	Supplement 3Manufacturing	Approved	None posted
Mar 21, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85870
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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