Urologic G In Plastic Container

NDA 18904, held by Hospira. Citric Acid; Magnesium Oxide; Sodium Carbonate.

As of Nov 13, 2026, NDA 18904 (Urologic G In Plastic Container), held by Hospira, was first approved by FDA on May 7, 2008, with 13 approved supplements and 0 published complete response letters.

First approved: May 7, 2008
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
May 7, 2008	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Urologic G In Plastic Container3.24GM/100ML;380MG/100ML;430MG/100ML · solution;irrigation	Citric Acid; Magnesium Oxide; Sodium Carbonate	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 18, 2009	Supplement 13Labeling	Approved	None posted
May 7, 2008	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted
Mar 3, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 10, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 22, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 24, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 30, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 25, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 18, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 25, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 15, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted

Identifiers

Application: NDA 18904
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