Irrigating Solution G In Plastic Container

NDA 18519, held by Baxter Hlthcare. Citric Acid; Magnesium Oxide; Sodium Carbonate.

As of Nov 13, 2026, NDA 18519 (Irrigating Solution G In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Jun 22, 1982, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 22, 1982
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jun 22, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Jul 17, 2002	Supplement 14Labeling · Standard review	Approved	Letter
Mar 30, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Sep 30, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 14, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
May 24, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 30, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 6, 1985	Supplement 4Labeling	Approved	None posted
Feb 28, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 22, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18519
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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