Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 5meq In Plastic Container, Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 10meq In Plastic Container, Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 15meq In Plastic Container

NDA 18629, held by Baxter Hlthcare. Dextrose; Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 18629 (Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 5meq In Plastic Container, Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 10meq In Plastic Container, Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 15meq In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Mar 23, 1982, with 30 approved supplements and 0 published complete response letters.

First approved: Mar 23, 1982
Review: Standard
Supplements approved: 30
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 31 submissions below

Date	Submission	Status	Documents
Mar 23, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

8 strengths and forms


Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 5meq In Plastic Container5GM/100ML;75MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 10meq In Plastic Container5GM/100ML;150MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 15meq In Plastic Container5GM/100ML;224MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container5GM/100ML;150MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 10meq In Plastic Container5GM/100ML;75MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container5GM/100ML;300MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 30meq In Plastic Container5GM/100ML;224MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx
Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 40meq In Plastic Container5GM/100ML;300MG/100ML;330MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Rx

All 31 submissions, including labeling and manufacturing supplements


Feb 21, 2019	Supplement 46Labeling · Standard review	Approved	Label Letter
Jul 11, 2018	Supplement 48	Approved	Letter
Jul 10, 2006	Supplement 39Labeling	Approved	None posted
Mar 15, 2004	Supplement 34Labeling	Approved	None posted
Aug 29, 2001	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 28, 2001	Supplement 30Labeling	Approved	None posted
Jan 28, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 17Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 27, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 28, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 28, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 3, 1985	Supplement 13Labeling	Approved	None posted
Jun 13, 1985	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 24, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 23, 1984	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 16, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 11, 1983	Supplement 9Labeling	Approved	None posted
May 25, 1982	Supplement 2Labeling	Approved	None posted
May 7, 1982	Supplement 1Labeling	Approved	None posted
Mar 23, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18629
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