Potassium Chloride

ANDA 85499, held by Baxter Hlthcare. Potassium Chloride.

As of Nov 15, 2026, ANDA 85499 (Potassium Chloride), held by Baxter Hlthcare, was first approved by FDA on Oct 13, 1977, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 13, 1977
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 13, 1977	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Sep 15, 2003	Supplement 14Labeling	Approved	None posted
Oct 17, 1994	Supplement 12Manufacturing	Approved	None posted
May 28, 1992	Supplement 11Labeling	Approved	None posted
Oct 23, 1991	Supplement 10Labeling	Approved	None posted
May 16, 1991	Supplement 9Manufacturing	Approved	None posted
Mar 22, 1991	Supplement 8Manufacturing	Approved	None posted
Feb 8, 1991	Supplement 7Labeling	Approved	None posted
Jan 13, 1989	Supplement 4Manufacturing	Approved	None posted
Jan 13, 1989	Supplement 3Manufacturing	Approved	None posted
Apr 16, 1987	Supplement 2Manufacturing	Approved	None posted
Oct 13, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85499
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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