Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container, Potassium Chloride 20meq In Dextrose 5% In Sodium Chloride 0.3% In Plastic Container, Potassium Chloride 30meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container

NDA 18876, held by Icu Medical Inc. Dextrose; Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 18876 (Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container, Potassium Chloride 20meq In Dextrose 5% In Sodium Chloride 0.3% In Plastic Container, Potassium Chloride 30meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container), held by Icu Medical Inc, was first approved by FDA on Jan 17, 1986, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1986
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 17, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

9 strengths and forms


Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;74.5MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 20meq In Dextrose 5% In Sodium Chloride 0.3% In Plastic Container5GM/100ML;149MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 30meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;224MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 40meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;298MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 5meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;74.5MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;149MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 15meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;224MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 20meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;298MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued
Potassium Chloride 5meq In Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;149MG/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Sodium Chloride	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Sep 5, 2013	Supplement 45Manufacturing · Standard review	Approved	None posted
Aug 24, 2001	Supplement 24Labeling · Standard review	Approved	None posted
Oct 29, 1998	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 20Labeling · Standard review	Approved	None posted
Jun 11, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 22, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 28, 1988	Supplement 6Labeling	Approved	None posted
Mar 28, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 31, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 9, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 11, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 17, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18876
Drugs@FDA: Overview at FDA
Company: 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