Alcohol 5% And Dextrose 5%

NDA 4589, held by B Braun. Alcohol; Dextrose.

As of Nov 14, 2026, NDA 4589 (Alcohol 5% And Dextrose 5%), held by B Braun, was first approved by FDA on Jan 17, 1946, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1946
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jan 17, 1946	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alcohol 5% And Dextrose 5%5ML/100ML;5GM/100ML · injectable;injection	Alcohol; Dextrose	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Oct 11, 1985	Supplement 11Labeling	Approved	None posted
Jun 14, 1985	Supplement 10Manufacturing	Approved	None posted
Jul 9, 1984	Supplement 7Manufacturing	Approved	None posted
Oct 4, 1982	Supplement 6Labeling	Approved	None posted
Jan 19, 1982	Supplement 5Labeling	Approved	None posted
Oct 1, 1980	Supplement 4Manufacturing	Approved	None posted
Feb 16, 1978	Supplement 3Manufacturing	Approved	None posted
Jun 28, 1977	Supplement 2Labeling	Approved	None posted
Jun 28, 1977	Supplement 1Manufacturing	Approved	None posted
Jan 17, 1946	Original application	Approved	None posted

Identifiers

Application: NDA 4589
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