Dextrose 2.5% In Plastic Container, Dextrose 5% In Plastic Container, Dextrose 7.7% In Plastic Container

NDA 19626, held by B Braun. Dextrose.

As of Nov 14, 2026, NDA 19626 (Dextrose 2.5% In Plastic Container, Dextrose 5% In Plastic Container, Dextrose 7.7% In Plastic Container), held by B Braun, was first approved by FDA on Feb 2, 1988, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 2, 1988
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 2, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

5 strengths and forms


Dextrose 2.5% In Plastic Container2.5GM/100ML · injectable;injection	Dextrose	Discontinued
Dextrose 5% In Plastic Container5GM/100ML · injectable;injection	Dextrose	RxReference drug
Dextrose 7.7% In Plastic Container7.7GM/100ML · injectable;injection	Dextrose	Discontinued
Dextrose 10% In Plastic Container10GM/100ML · injectable;injection	Dextrose	RxReference drug
Dextrose 70% In Plastic Container70GM/100ML · injectable;injection	Dextrose	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Oct 20, 2026	Supplement 51Labeling · Standard review	Approved	Label Letter
Nov 20, 2015	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 18, 2015	Supplement 30Manufacturing · Standard review	Approved	Label
Aug 22, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 13, 2004	Supplement 19Manufacturing · Standard review	Approved	Label Letter
Jul 23, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 8, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 12, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 11, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 25, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 1, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 26, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 29, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 18, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 13, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 21, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
May 5, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 21, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 16, 1988	Supplement 1Labeling	Approved	None posted
Feb 2, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19626
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