Sodium Chloride 0.9% In Sterile Plastic Container

NDA 19319, held by Baxter Hlthcare. Sodium Chloride.

As of Nov 13, 2026, NDA 19319 (Sodium Chloride 0.9% In Sterile Plastic Container), held by Baxter Hlthcare, was first approved by FDA on May 17, 1985, with 10 approved supplements and 0 published complete response letters.

First approved: May 17, 1985
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Slushed solution is used to create regional hypothermia in order to reduce and minimize manifestations of warm-temperature ischemia. Temperature probes may be used to determine requirements for replacement or addition of slushed solution.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
May 17, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Chloride 0.9% In Sterile Plastic Container900MG/100ML · solution for slush;irrigation	Sodium Chloride	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Sep 29, 2014	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 15, 2007	Supplement 12Manufacturing	Approved	None posted
Aug 14, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Sep 30, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 2, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
May 24, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
May 17, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19319
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