Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container

NDA 19686, held by Otsuka Icu Medcl. Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 19686 (Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Oct 17, 1988, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 17, 1988
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE These solutions are indicated in patients requiring parenteral administration of potassium chloride and sodium chloride.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 17, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container149MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container298MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Rx

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 10, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Sep 8, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
May 19, 1999	Supplement 11Labeling	Approved	None posted
Aug 29, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 17, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19686
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