Sterile Water In Plastic Container

NDA 16734, held by B Braun. Sterile Water For Irrigation.

As of Nov 14, 2026, NDA 16734 (Sterile Water In Plastic Container), held by B Braun, was first approved by FDA on Sep 10, 1970, with 42 approved supplements and 0 published complete response letters.

First approved: Sep 10, 1970
Review: Standard
Supplements approved: 42
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 43 submissions below

Date	Submission	Status	Documents
Sep 10, 1970	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sterile Water In Plastic Container100% · liquid;irrigation	Sterile Water For Irrigation	RxReference drug

All 43 submissions, including labeling and manufacturing supplements


Mar 30, 2015	Supplement 49Manufacturing · Standard review	Approved	None posted
May 8, 2013	Supplement 48Manufacturing · Standard review	Approved	None posted
Jul 8, 2002	Supplement 44Manufacturing · Standard review	Approved	None posted
Apr 3, 2002	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 42Manufacturing · Standard review	Approved	None posted
Mar 25, 1998	Supplement 41Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 19, 1988	Supplement 38Manufacturing · Standard review	Approved	None posted
Mar 5, 1987	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 30, 1985	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 17, 1985	Supplement 35Labeling	Approved	None posted
May 17, 1985	Supplement 32Manufacturing · Standard review	Approved	None posted
May 15, 1985	Supplement 31Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 12, 1982	Supplement 30Labeling	Approved	None posted
Nov 6, 1981	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 27, 1981	Supplement 26Labeling	Approved	None posted
Oct 27, 1981	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 28, 1981	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 24, 1981	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 3, 1981	Supplement 20Labeling	Approved	None posted
Jul 16, 1980	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 15, 1980	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 4, 1980	Supplement 17Labeling	Approved	None posted
Sep 25, 1979	Supplement 22Labeling	Approved	None posted
Sep 24, 1979	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 20, 1979	Supplement 19Labeling	Approved	None posted
Apr 26, 1979	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 27, 1978	Supplement 13Labeling	Approved	None posted
Dec 27, 1978	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 27, 1978	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 27, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 3, 1978	Supplement 16Manufacturing · Standard review	Approved	None posted
May 26, 1978	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 6, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 19, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 4, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 31, 1976	Supplement 7Labeling	Approved	None posted
Apr 2, 1976	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 2, 1976	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 2, 1976	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 4, 1974	Supplement 3Labeling	Approved	None posted
Sep 10, 1970	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16734
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