Dextrose 30% In Plastic Container

NDA 19345, held by Otsuka Icu Medcl. Dextrose.

As of Nov 13, 2026, NDA 19345 (Dextrose 30% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Jan 26, 1985, with 27 approved supplements and 0 published complete response letters.

First approved: Jan 26, 1985
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Jan 26, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dextrose 30% In Plastic Container30GM/100ML · injectable;injection	Dextrose	RxReference drug

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 14, 2018	Supplement 47Labeling · Standard review	Approved	Label Letter
Feb 22, 2016	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 2, 2003	Supplement 30Labeling	Approved	None posted
Nov 1, 2002	Supplement 28Manufacturing · Standard review	Approved	None posted
May 27, 1999	Supplement 27Labeling	Approved	None posted
Dec 1, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 24Labeling	Approved	None posted
Jun 11, 1997	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 28, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 13, 1993	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 21, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 6, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 13, 1987	Supplement 5Labeling	Approved	None posted
Feb 13, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 29, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 13, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 26, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19345
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