Potassium Chloride In Plastic Container

Treats potassium deficiency states. ANDA 88901, held by Fresenius Kabi USA. Potassium Chloride.

As of Nov 15, 2026, ANDA 88901 (Potassium Chloride In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Jan 25, 1985, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 25, 1985
Supplements approved: 16
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 17 submissions below

Date	Submission	Status	Documents
Jan 25, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride In Plastic Container2MEQ/ML · injectable;injection	Potassium Chloride	Rx

All 17 submissions, including labeling and manufacturing supplements


Dec 2, 2022	Supplement 40Labeling · Standard review	Approved	None posted
Nov 3, 2022	Supplement 33Labeling · Standard review	Approved	None posted
May 21, 2007	Supplement 24Manufacturing	Approved	None posted
Jan 16, 2007	Supplement 23Labeling	Approved	None posted
Oct 18, 2005	Supplement 21Labeling	Approved	None posted
Mar 6, 1997	Supplement 16Labeling	Approved	None posted
Nov 17, 1994	Supplement 10Manufacturing	Approved	None posted
Jun 25, 1992	Supplement 15Labeling	Approved	None posted
Mar 19, 1991	Supplement 14Labeling	Approved	None posted
Feb 4, 1991	Supplement 13Labeling	Approved	None posted
Jan 25, 1991	Supplement 11Manufacturing	Approved	None posted
Dec 18, 1990	Supplement 12Labeling	Approved	None posted
Oct 29, 1987	Supplement 9Manufacturing	Approved	None posted
Dec 17, 1985	Supplement 7Manufacturing	Approved	None posted
Mar 20, 1985	Supplement 2Manufacturing	Approved	None posted
Mar 20, 1985	Supplement 1Manufacturing	Approved	None posted
Jan 25, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88901
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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