Potassium Chloride 0.075% In Dextrose 5% In Plastic Container, Potassium Chloride 0.15% In Dextrose 5% In Plastic Container, Potassium Chloride 0.22% In Dextrose 5% In Plastic Container

NDA 18744, held by B Braun. Dextrose; Potassium Chloride.

As of Nov 14, 2026, NDA 18744 (Potassium Chloride 0.075% In Dextrose 5% In Plastic Container, Potassium Chloride 0.15% In Dextrose 5% In Plastic Container, Potassium Chloride 0.22% In Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Nov 9, 1982, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1982
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 9, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Potassium Chloride 0.075% In Dextrose 5% In Plastic Container5GM/100ML;75MG/100ML · injectable;injection	Dextrose; Potassium Chloride	Discontinued
Potassium Chloride 0.15% In Dextrose 5% In Plastic Container5GM/100ML;150MG/100ML · injectable;injection	Dextrose; Potassium Chloride	Discontinued
Potassium Chloride 0.22% In Dextrose 5% In Plastic Container5GM/100ML;220MG/100ML · injectable;injection	Dextrose; Potassium Chloride	Discontinued
Potassium Chloride 0.3% In Dextrose 5% In Plastic Container5GM/100ML;300MG/100ML · injectable;injection	Dextrose; Potassium Chloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 11, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 10, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 10, 1985	Supplement 5Labeling · Standard review	Approved	None posted
Sep 5, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 24, 1985	Supplement 7Labeling · Standard review	Approved	None posted
Apr 3, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 9, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18744
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