Dextrose 10% And Sodium Chloride 0.45% In Plastic Container

NDA 18229, held by B Braun. Dextrose; Sodium Chloride.

As of Nov 13, 2026, NDA 18229 (Dextrose 10% And Sodium Chloride 0.45% In Plastic Container), held by B Braun, was first approved by FDA on Jun 28, 1979, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1979
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jun 28, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dextrose 10% And Sodium Chloride 0.45% In Plastic Container10GM/100ML;450MG/100ML · injectable;injection	Dextrose; Sodium Chloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 11, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 18, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 2, 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
Jan 24, 1983	Supplement 6Labeling · Standard review	Approved	None posted
Oct 26, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 18, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 6, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 12, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 16, 1979	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 9, 1979	Supplement 2Labeling · Standard review	Approved	None posted
Jun 28, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18229
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