Isolyte E In Dextrose 5% In Plastic Container

NDA 19867, held by B Braun. Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate.

As of Nov 13, 2026, NDA 19867 (Isolyte E In Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Dec 20, 1993, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1993
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 20, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isolyte E In Dextrose 5% In Plastic Container35MG/100ML;5GM/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jul 1, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 26, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19867
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