Tools / Drug approvals and letters / Drugs Dextrose 5% In Plastic Container NDA 19466, held by Hospira . Dextrose
As of Nov 13, 2026, NDA 19466 (Dextrose 5% In Plastic Container), held by Hospira, was first approved by FDA on Jul 15, 1985, with 37 approved supplements and 0 published complete response letters.
First approved : Jul 15, 1985 Review : Standard Supplements approved : 37 Complete response letters : 0
What It's For From the FDA-approved label (Indications and Usage) Dextrose Injection (5%) 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 38 submissions below Date Submission Status Documents Jul 15, 1985 Original applicationNew formulation or manufacturer · Standard review Approved None posted
Products 1 strengths and forms Product Active ingredient Marketing Dextrose 5% In Plastic Container5GM/100ML · injectable;injection Dextrose Rx Reference drug
All 38 submissions, including labeling and manufacturing supplements Date Submission Status Documents Jun 6, 2025 Supplement 63Labeling · Standard review Approved Label Letter May 29, 2019 Supplement 62Manufacturing Approved None posted Jun 10, 2016 Supplement 57Labeling · Standard review Approved Letter Nov 1, 2002 Supplement 40Manufacturing · Standard review Approved None posted Apr 6, 2000 Supplement 39Manufacturing · Standard review Approved None posted Apr 6, 2000 Supplement 38Labeling Approved None posted Apr 6, 2000 Supplement 37Manufacturing · Standard review Approved None posted Mar 31, 1999 Supplement 36Labeling Approved None posted Dec 1, 1998 Supplement 35Manufacturing · Standard review Approved None posted Aug 20, 1997 Supplement 34Manufacturing · Standard review Approved None posted Aug 20, 1997 Supplement 32Labeling Approved None posted Jun 11, 1997 Supplement 33Manufacturing · Standard review Approved None posted Aug 27, 1996 Supplement 28Manufacturing · Standard review Approved None posted Mar 4, 1996 Supplement 31Manufacturing · Standard review Approved None posted Jan 24, 1996 Supplement 27Manufacturing · Standard review Approved None posted Aug 18, 1995 Supplement 30Manufacturing · Standard review Approved None posted May 31, 1995 Supplement 29Manufacturing · Standard review Approved None posted Jan 5, 1995 Supplement 25Manufacturing · Standard review Approved None posted Sep 23, 1994 Supplement 26Manufacturing · Standard review Approved None posted Feb 25, 1994 Supplement 24Manufacturing · Standard review Approved None posted Feb 16, 1993 Supplement 16Labeling Approved None posted Jan 28, 1992 Supplement 18Manufacturing · Standard review Approved None posted Dec 30, 1991 Supplement 21Manufacturing · Standard review Approved None posted Sep 10, 1991 Supplement 17Manufacturing · Standard review Approved None posted Nov 2, 1990 Supplement 15Manufacturing · Standard review Approved None posted Mar 9, 1990 Supplement 14Manufacturing · Standard review Approved None posted Feb 22, 1990 Supplement 12Manufacturing · Standard review Approved None posted Jan 11, 1990 Supplement 13Manufacturing · Standard review Approved None posted Sep 20, 1989 Supplement 9Labeling Approved None posted Aug 3, 1989 Supplement 11Manufacturing · Standard review Approved None posted Jul 18, 1989 Supplement 10Manufacturing · Standard review Approved None posted Feb 6, 1989 Supplement 6Manufacturing · Standard review Approved None posted Nov 26, 1986 Supplement 5Manufacturing · Standard review Approved None posted Aug 11, 1986 Supplement 4Manufacturing · Standard review Approved None posted Aug 8, 1986 Supplement 3Manufacturing · Standard review Approved None posted May 27, 1986 Supplement 2Manufacturing · Standard review Approved None posted Jan 17, 1986 Supplement 1Labeling Approved None posted Jul 15, 1985 Original applicationNew formulation or manufacturer · Standard review Approved None posted
Identifiers
Application NDA 19466 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
