Potassium Chloride 10meq In Plastic Container, Potassium Chloride 20meq In Plastic Container, Potassium Chloride 30meq In Plastic Container

Treats potassium deficiency states. NDA 20161, held by Otsuka Icu Medcl. Potassium Chloride.

As of Nov 13, 2026, NDA 20161 (Potassium Chloride 10meq In Plastic Container, Potassium Chloride 20meq In Plastic Container, Potassium Chloride 30meq In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Nov 30, 1992, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1992
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 30, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

6 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride 10meq In Plastic Container745MG/100ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 20meq In Plastic Container1.49GM/100ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 30meq In Plastic Container2.24GM/100ML · injectable;injection	Potassium Chloride	DiscontinuedReference drug
Potassium Chloride 40meq In Plastic Container2.98GM/100ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 10meq In Plastic Container14.9MG/ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 20meq In Plastic Container29.8MG/ML · injectable;injection	Potassium Chloride	RxReference drug

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 1, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 30, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 24, 1999	Supplement 4Labeling	Approved	None posted
Aug 11, 1998	Supplement 8Labeling	Approved	None posted
Aug 11, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 11, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 11, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 5, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
May 24, 1994	Supplement 2Labeling	Approved	None posted
Nov 30, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20161
Drugs@FDA: Overview at FDA
Company: Otsuka ICU 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