Dextrose 5% And Sodium Chloride 0.9% In Plastic Container

NDA 18026, held by B Braun. Dextrose; Sodium Chloride.

As of Nov 13, 2026, NDA 18026 (Dextrose 5% And Sodium Chloride 0.9% In Plastic Container), held by B Braun, was first approved by FDA on Feb 8, 1978, with 18 approved supplements and 0 published complete response letters.

First approved: Feb 8, 1978
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Feb 8, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;900MG/100ML · injectable;injection	Dextrose; Sodium Chloride	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Sep 11, 1990	Supplement 19Manufacturing	Approved	None posted
Feb 18, 1986	Supplement 14Manufacturing	Approved	None posted
Jun 25, 1985	Supplement 17Labeling	Approved	None posted
May 17, 1985	Supplement 15Manufacturing	Approved	None posted
Apr 3, 1985	Supplement 16Manufacturing	Approved	None posted
Jan 24, 1983	Supplement 12Labeling	Approved	None posted
Oct 26, 1981	Supplement 13Manufacturing	Approved	None posted
Oct 24, 1980	Supplement 11Manufacturing	Approved	None posted
Aug 6, 1980	Supplement 10Manufacturing	Approved	None posted
Jul 16, 1980	Supplement 9Manufacturing	Approved	None posted
Feb 12, 1980	Supplement 8Manufacturing	Approved	None posted
Oct 16, 1979	Supplement 6Manufacturing	Approved	None posted
Oct 9, 1979	Supplement 7Labeling	Approved	None posted
Jun 8, 1979	Supplement 5Manufacturing	Approved	None posted
Sep 29, 1978	Supplement 2Labeling	Approved	None posted
Sep 29, 1978	Supplement 3Manufacturing	Approved	None posted
Sep 26, 1978	Supplement 4Manufacturing	Approved	None posted
Mar 23, 1978	Supplement 1Manufacturing	Approved	None posted
Feb 8, 1978	Original application	Approved	None posted

Identifiers

Application: NDA 18026
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