Isolyte H W/ Dextrose 5% In Plastic Container

NDA 18273, held by B Braun. Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 18273 (Isolyte H W/ Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Oct 6, 1980, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1980
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 6, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isolyte H W/ Dextrose 5% In Plastic Container5GM/100ML;30MG/100ML;97MG/100ML;220MG/100ML;140MG/100ML · injectable;injection	Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Sep 11, 1990	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 28, 1987	Supplement 14Labeling · Standard review	Approved	None posted
Jul 9, 1987	Supplement 13Labeling · Standard review	Approved	None posted
Feb 18, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 25, 1985	Supplement 12Labeling · Standard review	Approved	None posted
Jun 28, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 10, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 17, 1983	Supplement 8Labeling · Standard review	Approved	None posted
Dec 16, 1981	Supplement 5Labeling · Standard review	Approved	None posted
Oct 26, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 30, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 11, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 3, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 6, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18273
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