Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Container

NDA 19708, held by B Braun. Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 19708 (Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Container), held by B Braun, was first approved by FDA on Sep 29, 1989, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1989
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 29, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container37MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Container75MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Container110MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container150MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 0.22% In Sodium Chloride 0.9% In Plastic Container220MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 0.3% In Sodium Chloride 0.9% In Plastic Container300MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 17, 2026	Supplement 40Labeling · Standard review	Approved	Letter Label
Aug 22, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 31, 2005	Supplement 16Labeling · Standard review	Approved	Letter
Sep 27, 2004	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 23, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 8, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 12, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
May 4, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 25, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 29, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 29, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 21, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 18, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 29, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19708
Drugs@FDA: Overview at FDA
Company: B. Braun 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