Sodium Chloride 3% In Plastic Container, Sodium Chloride 5% In Plastic Container

NDA 19022, held by Baxter Hlthcare. Sodium Chloride.

As of Nov 13, 2026, NDA 19022 (Sodium Chloride 3% In Plastic Container, Sodium Chloride 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Nov 1, 1983, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1983
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Nov 1, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Sodium Chloride 3% In Plastic Container3GM/100ML · injectable;injection	Sodium Chloride	RxReference drug
Sodium Chloride 5% In Plastic Container5GM/100ML · injectable;injection	Sodium Chloride	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Sep 14, 2018	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 22, 2014	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 6, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 26, 2005	Supplement 22Manufacturing · Standard review	Approved	Label Letter
Jun 9, 2005	Supplement 21Labeling · Standard review	Approved	Letter Label
Apr 3, 2002	Supplement 17Labeling · Standard review	Approved	Letter
Aug 14, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 24, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
May 24, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 13, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 26, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 26, 1985	Supplement 4Labeling	Approved	None posted
Dec 6, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 22, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 1, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19022
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