Isolyte S W/ Dextrose 5% In Plastic Container

NDA 18274, held by B Braun. Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate.

As of Nov 13, 2026, NDA 18274 (Isolyte S W/ Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Aug 11, 1980, with 16 approved supplements and 0 published complete response letters.

First approved: Aug 11, 1980
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Aug 11, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isolyte S W/ Dextrose 5% In Plastic Container5GM/100ML;30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML · injectable;injection	Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 11, 1990	Supplement 18Manufacturing	Approved	None posted
Dec 29, 1987	Supplement 16Labeling	Approved	None posted
Nov 5, 1987	Supplement 11Manufacturing	Approved	None posted
Jul 9, 1987	Supplement 15Labeling	Approved	None posted
Feb 18, 1986	Supplement 9Manufacturing	Approved	None posted
Feb 14, 1986	Supplement 13Labeling	Approved	None posted
Jun 28, 1985	Supplement 10Manufacturing	Approved	None posted
Apr 3, 1985	Supplement 12Manufacturing	Approved	None posted
Dec 10, 1984	Supplement 6Manufacturing	Approved	None posted
Jan 17, 1983	Supplement 8Labeling	Approved	None posted
Dec 16, 1981	Supplement 5Labeling	Approved	None posted
Oct 26, 1981	Supplement 7Manufacturing	Approved	None posted
Dec 12, 1980	Supplement 3Manufacturing	Approved	None posted
Dec 10, 1980	Supplement 4Manufacturing	Approved	None posted
Nov 24, 1980	Supplement 2Manufacturing	Approved	None posted
Oct 7, 1980	Supplement 1Manufacturing	Approved	None posted
Aug 11, 1980	Original application	Approved	None posted

Identifiers

Application: NDA 18274
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