Acetic Acid 0.25% In Plastic Container

NDA 18523, held by Baxter Hlthcare. Acetic Acid, Glacial.

As of Nov 13, 2026, NDA 18523 (Acetic Acid 0.25% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Feb 19, 1982, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 19, 1982
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 19, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetic Acid 0.25% In Plastic Container250MG/100ML · solution;irrigation, urethral	Acetic Acid, Glacial	Rx

All 14 submissions, including labeling and manufacturing supplements


Sep 26, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 28, 2011	Supplement 20Manufacturing	Approved	None posted
May 26, 1999	Supplement 15Labeling	Approved	None posted
Sep 30, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 14, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
May 18, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 30, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 26, 1985	Supplement 6Labeling	Approved	None posted
Jan 24, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 19, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18523
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