Potassium Chloride 5meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 20meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container

NDA 19308, held by Baxter Hlthcare. Dextrose; Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 19308 (Potassium Chloride 5meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container, Potassium Chloride 20meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Apr 5, 1985, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 5, 1985
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Apr 5, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

7 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride 5meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;150MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;150MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 20meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;300MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;75MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 20meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;150MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 30meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;224MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Potassium Chloride 40meq In Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;300MG/100ML;900MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 21, 2019	Supplement 30Labeling · Standard review	Approved	Label Letter
Sep 10, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
Apr 20, 2007	Supplement 23Labeling · Standard review	Approved	Letter Label
Aug 26, 2005	Supplement 22Manufacturing · Standard review	Approved	Label Letter
Jun 2, 2004	Supplement 20Labeling · Standard review	Approved	Letter
Apr 14, 2003	Supplement 17Labeling · Standard review	Approved	Letter
Aug 14, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 24, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 5, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19308
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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