Acetic Acid 0.25% In Plastic Container

NDA 18161, held by B Braun. Acetic Acid, Glacial.

As of Nov 14, 2026, NDA 18161 (Acetic Acid 0.25% In Plastic Container), held by B Braun, was first approved by FDA on Aug 6, 1979, with 20 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1979
Review: Standard
Supplements approved: 20
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 21 submissions below

Date	Submission	Status	Documents
Aug 6, 1979	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 21 submissions, including labeling and manufacturing supplements


May 15, 2003	Supplement 22Labeling	Approved	None posted
Aug 28, 2002	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 16, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 5, 1987	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 3, 1986	Supplement 15Labeling	Approved	None posted
Jun 4, 1985	Supplement 11Manufacturing · Standard review	Approved	None posted
May 17, 1985	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 9, 1982	Supplement 10Labeling	Approved	None posted
Nov 6, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 28, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 24, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 18, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 16, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 15, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 4, 1979	Supplement 3Labeling	Approved	None posted
Sep 25, 1979	Supplement 2Labeling	Approved	None posted
Sep 24, 1979	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 6, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18161
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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