Potassium Chloride

ANDA 83163, held by Intl Medication. Potassium Chloride.

As of Nov 15, 2026, ANDA 83163 (Potassium Chloride), held by Intl Medication, was first approved by FDA on Aug 29, 1975, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1975
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Aug 29, 1975	Original application	Approved	None posted

Products

1 strengths and forms

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

All 20 submissions, including labeling and manufacturing supplements


Mar 21, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Dec 2, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Jan 14, 1998	Supplement 20Manufacturing	Approved	None posted
Jun 18, 1996	Supplement 25Manufacturing	Approved	None posted
Jun 18, 1996	Supplement 23Labeling	Approved	None posted
Jun 18, 1996	Supplement 22Manufacturing	Approved	None posted
Sep 19, 1995	Supplement 24Manufacturing	Approved	None posted
Jun 17, 1994	Supplement 21Manufacturing	Approved	None posted
Oct 29, 1993	Supplement 19Manufacturing	Approved	None posted
Aug 27, 1993	Supplement 18Manufacturing	Approved	None posted
Feb 3, 1993	Supplement 17Manufacturing	Approved	None posted
Jun 15, 1992	Supplement 15Labeling	Approved	None posted
Mar 26, 1992	Supplement 16Labeling	Approved	None posted
Apr 4, 1991	Supplement 14Labeling	Approved	None posted
Feb 7, 1991	Supplement 11Manufacturing	Approved	None posted
Feb 7, 1991	Supplement 10Manufacturing	Approved	None posted
Mar 12, 1987	Supplement 6Manufacturing	Approved	None posted
Feb 5, 1987	Supplement 9Manufacturing	Approved	None posted
Feb 5, 1987	Supplement 8Manufacturing	Approved	None posted
Aug 29, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 83163
Drugs@FDA: Overview at FDA
Company: International Medication Systems

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