Dextrose 70% In Plastic Container

NDA 19893, held by Otsuka Icu Medcl. Dextrose.

As of Nov 13, 2026, NDA 19893 (Dextrose 70% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Dec 26, 1989, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 26, 1989
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 70% Dextrose Injection, USP (concentrated dextrose in water) in Pharmacy Bulk Packages is indicated for use with automated compounding devices for preparing intravenous nutritional admixtures in the pharmacy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 26, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dextrose 70% In Plastic Container70GM/100ML · injectable;injection	Dextrose	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Dec 18, 2003	Supplement 16Labeling	Approved	None posted
Nov 1, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 16, 1999	Supplement 13Labeling	Approved	None posted
May 19, 1999	Supplement 12Labeling	Approved	None posted
Jan 5, 1999	Supplement 11Labeling	Approved	None posted
Aug 22, 1997	Supplement 10Labeling	Approved	None posted
Aug 27, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 13, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 21, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 31, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 26, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19893
Drugs@FDA: Overview at FDA
Company: Otsuka ICU 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