Sodium Chloride 0.45% In Plastic Container

NDA 17864, held by Baxter Hlthcare. Sodium Chloride.

As of Nov 13, 2026, NDA 17864 (Sodium Chloride 0.45% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on May 30, 1980, with 36 approved supplements and 0 published complete response letters.

First approved: May 30, 1980
Review: Standard
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 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
Sodium Chloride 0.45% In Plastic Container450MG/100ML · solution;irrigation	Sodium Chloride	Discontinued

All 37 submissions, including labeling and manufacturing supplements


Aug 29, 2001	Supplement 42Manufacturing · Standard review	Approved	None posted
Jan 28, 2000	Supplement 41Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 40Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 38Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 39Manufacturing · Standard review	Approved	None posted
Dec 8, 1993	Supplement 37Manufacturing · Standard review	Approved	None posted
May 8, 1991	Supplement 35Labeling	Approved	None posted
Mar 26, 1991	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 32Manufacturing · Standard review	Approved	None posted
May 24, 1990	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 28Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 27, 1986	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 28, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 28, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 13, 1985	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 15, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 26, 1985	Supplement 24Labeling	Approved	None posted
Jan 24, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 24, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 16, 1984	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 3, 1982	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 16, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 17, 1982	Supplement 15Labeling	Approved	None posted
Dec 21, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 20, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 13, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 9, 1981	Supplement 10Manufacturing · 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 17864
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