Sterile Water

NDA 17428, held by Baxter Hlthcare. Sterile Water For Irrigation.

As of Nov 14, 2026, NDA 17428 (Sterile Water), held by Baxter Hlthcare, was first approved by FDA on Dec 31, 1974, with 55 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1974
Review: Standard
Supplements approved: 55
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 56 submissions below

Date	Submission	Status	Documents
Dec 31, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sterile Water100% · liquid;irrigation	Sterile Water For Irrigation	RxReference drug

All 56 submissions, including labeling and manufacturing supplements


Oct 17, 2017	Supplement 71Labeling · Standard review	Approved	Label Letter
Aug 4, 2016	Supplement 73Manufacturing · Standard review	Approved	None posted
Sep 28, 2011	Supplement 69Manufacturing	Approved	None posted
Sep 30, 1994	Supplement 58Manufacturing · Standard review	Approved	None posted
Sep 14, 1993	Supplement 59Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 56Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 57Manufacturing · Standard review	Approved	None posted
May 18, 1990	Supplement 55Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 54Manufacturing · Standard review	Approved	None posted
Oct 30, 1986	Supplement 53Manufacturing · Standard review	Approved	None posted
Apr 6, 1985	Supplement 52Labeling	Approved	None posted
Jan 24, 1985	Supplement 40Manufacturing · Standard review	Approved	None posted
Jan 24, 1985	Supplement 48Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 50Manufacturing · Standard review	Approved	None posted
Dec 22, 1982	Supplement 43Manufacturing · Standard review	Approved	None posted
Dec 22, 1982	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 22, 1982	Supplement 45Manufacturing · Standard review	Approved	None posted
Jun 7, 1982	Supplement 46Manufacturing · Standard review	Approved	None posted
Apr 9, 1982	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 9, 1982	Supplement 34Labeling	Approved	None posted
Apr 9, 1982	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 1, 1982	Supplement 31Labeling	Approved	None posted
Feb 16, 1982	Supplement 42Manufacturing · Standard review	Approved	None posted
Aug 6, 1981	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 29, 1981	Supplement 37Manufacturing · Standard review	Approved	None posted
Jun 10, 1981	Supplement 41Manufacturing · Standard review	Approved	None posted
Feb 23, 1981	Supplement 36Manufacturing · Standard review	Approved	None posted
Jan 22, 1981	Supplement 35Labeling	Approved	None posted
Jul 31, 1980	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 2, 1980	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 2, 1980	Supplement 28Labeling	Approved	None posted
Dec 19, 1979	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 11, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 11, 1979	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 11, 1979	Supplement 20Manufacturing · Standard review	Approved	None posted
May 29, 1979	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 14, 1979	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 14, 1979	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 8, 1979	Supplement 25Labeling	Approved	None posted
Jun 20, 1978	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 5, 1977	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 20, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 12, 1977	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 12, 1977	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 26, 1977	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 17, 1976	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 10, 1976	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 10, 1976	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 6, 1976	Supplement 6Labeling	Approved	None posted
Oct 6, 1976	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 28, 1976	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 2, 1976	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 18, 1976	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 16, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 7, 1975	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 31, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Show all 56

Identifiers

Application: NDA 17428
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