Ionosol T And Dextrose 5% In Plastic Container

NDA 19514, held by Hospira. Dextrose; Potassium Chloride; Potassium Lactate; Sodium Chloride; Sodium Phosphate, Monobasic Anhydrous.

As of Nov 13, 2026, NDA 19514 (Ionosol T And Dextrose 5% In Plastic Container), held by Hospira, was first approved by FDA on May 8, 1986, with 16 approved supplements and 0 published complete response letters.

First approved: May 8, 1986
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
May 8, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ionosol T And Dextrose 5% In Plastic Container5GM/100ML;111MG/100ML;256MG/100ML;146MG/100ML;207MG/100ML · injectable;injection	Dextrose; Potassium Chloride; Potassium Lactate; Sodium Chloride; Sodium Phosphate, Monobasic Anhydrous	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Feb 11, 2000	Supplement 21Labeling · Standard review	Approved	None posted
Oct 29, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 22, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 13, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
May 8, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19514
Drugs@FDA: Overview at FDA
Company: Hospira

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