Isolyte E In Plastic Container

NDA 19718, held by B Braun. Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate.

As of Nov 13, 2026, NDA 19718 (Isolyte E In Plastic Container), held by B Braun, was first approved by FDA on Sep 29, 1989, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1989
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Sep 29, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 1, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 26, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 12, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 29, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 21, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 18, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 29, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19718
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