Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer'S In Plastic Container, Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer'S In Plastic Container, Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container

NDA 19367, held by Baxter Hlthcare. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 13, 2026, NDA 19367 (Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer'S In Plastic Container, Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer'S In Plastic Container, Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Apr 5, 1985, with 21 approved supplements and 0 published complete response letters.

First approved: Apr 5, 1985
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

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

Products

8 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 15meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 30meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Potassium Chloride 40meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 5, 2025	Supplement 42Labeling · Standard review	Approved	Letter Label
Oct 9, 2019	Supplement 36Labeling · Standard review	Approved	Label Letter
Dec 6, 2017	Supplement 30Labeling · Standard review	Approved	Label Letter
Sep 30, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
Apr 26, 2013	Supplement 29Manufacturing · Standard review	Approved	None posted
Oct 19, 2011	Supplement 26Labeling	Approved	Label Letter
Aug 26, 2005	Supplement 22Manufacturing · Standard review	Approved	Letter Label
Jun 7, 2005	Supplement 21Labeling · Standard review	Approved	Label Letter
Jan 3, 2003	Supplement 15Labeling · Standard review	Approved	Letter
Aug 14, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 24, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 5, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19367
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