Sodium Chloride 0.9% And Potassium Chloride 0.075% In Plastic Container, Sodium Chloride 0.9% And Potassium Chloride 0.15% In Plastic Container, Sodium Chloride 0.9% And Potassium Chloride 0.22% In Plastic Container

NDA 18722, held by B Braun. Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 18722 (Sodium Chloride 0.9% And Potassium Chloride 0.075% In Plastic Container, Sodium Chloride 0.9% And Potassium Chloride 0.15% In Plastic Container, Sodium Chloride 0.9% And Potassium Chloride 0.22% In Plastic Container), held by B Braun, was first approved by FDA on Nov 9, 1982, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1982
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

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

Products

4 strengths and forms

Product	Active ingredient	Marketing
Sodium Chloride 0.9% And Potassium Chloride 0.075% In Plastic Container75MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Sodium Chloride 0.9% And Potassium Chloride 0.15% In Plastic Container150MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Sodium Chloride 0.9% And Potassium Chloride 0.22% In Plastic Container220MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued
Sodium Chloride 0.9% And Potassium Chloride 0.3% In Plastic Container300MG/100ML;900MG/100ML · injectable;injection	Potassium Chloride; Sodium Chloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 11, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
May 24, 1985	Supplement 4Labeling · Standard review	Approved	None posted
Apr 3, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 9, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18722
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