Potassium Chloride

ANDA 83345, held by Hospira. Potassium Chloride.

As of Nov 15, 2026, ANDA 83345 (Potassium Chloride), held by Hospira, was first approved by FDA on Feb 13, 1974, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1974
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 13, 1974	Original application	Approved	None posted

Products

3 strengths and forms


Potassium Chloride1.5MEQ/ML · injectable;injection	Potassium Chloride	Discontinued
Potassium Chloride2MEQ/ML · injectable;injection	Potassium Chloride	Discontinued
Potassium Chloride1MEQ/ML · injectable;injection	Potassium Chloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Dec 11, 2002	Supplement 26Manufacturing	Approved	None posted
Aug 12, 1994	Supplement 23Labeling	Approved	None posted
Jun 2, 1992	Supplement 22Labeling	Approved	None posted
Nov 7, 1991	Supplement 21Labeling	Approved	None posted
Aug 23, 1989	Supplement 20Labeling	Approved	None posted
Aug 29, 1985	Supplement 19Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 18Manufacturing	Approved	None posted
Feb 13, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 83345
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