Sterile Water In Plastic Container

NDA 17866, held by Baxter Hlthcare. Sterile Water For Irrigation.

As of Nov 13, 2026, NDA 17866 (Sterile Water In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on May 30, 1980, with 40 approved supplements and 0 published complete response letters.

First approved: May 30, 1980
Review: Standard
Supplements approved: 40
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sterile Water for Irrigation is indicated for use as an irrigant. Sterile Water for Irrigation is indicated for use as an irrigant.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
May 30, 1980	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	Rx

All 41 submissions, including labeling and manufacturing supplements


Oct 17, 2017	Supplement 52Labeling · Standard review	Approved	Label Letter
Sep 26, 2014	Supplement 53Manufacturing · Standard review	Approved	None posted
Aug 29, 2001	Supplement 44Manufacturing · Standard review	Approved	None posted
Jan 28, 2000	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 42Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 41Manufacturing · Standard review	Approved	None posted
Dec 8, 1993	Supplement 39Manufacturing · Standard review	Approved	None posted
May 8, 1991	Supplement 37Labeling	Approved	None posted
Mar 26, 1991	Supplement 36Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 34Manufacturing · Standard review	Approved	None posted
May 18, 1990	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 30Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 8, 1986	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 27, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 28, 1985	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 28, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 13, 1985	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 15, 1985	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 15, 1985	Supplement 25Labeling	Approved	None posted
Jan 24, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 24, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 16, 1984	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 22, 1982	Supplement 14Labeling	Approved	None posted
Dec 22, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 3, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 16, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 17, 1982	Supplement 16Labeling	Approved	None posted
Dec 21, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 20, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 13, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 29, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
May 29, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 21, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 6, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 31, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
May 30, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17866
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