Sodium Chloride 0.45% In Plastic Container, Sodium Chloride 0.9% In Plastic Container, Sodium Chloride 3% In Plastic Container

NDA 19635, held by B Braun. Sodium Chloride.

As of Nov 13, 2026, NDA 19635 (Sodium Chloride 0.45% In Plastic Container, Sodium Chloride 0.9% In Plastic Container, Sodium Chloride 3% In Plastic Container), held by B Braun, was first approved by FDA on Mar 9, 1988, with 26 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1988
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 0.9% Sodium Chloride Injection USP is indicated as pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Mar 9, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

5 strengths and forms


Sodium Chloride 0.45% In Plastic Container450MG/100ML · injectable;injection	Sodium Chloride	RxReference drug
Sodium Chloride 0.9% In Plastic Container900MG/100ML · injectable;injection	Sodium Chloride	RxReference drug
Sodium Chloride 3% In Plastic Container3GM/100ML · injectable;injection	Sodium Chloride	Rx
Sodium Chloride 5% In Plastic Container5GM/100ML · injectable;injection	Sodium Chloride	Rx
Sodium Chloride 0.9%90MG/10ML (9MG/ML) · solution;injection	Sodium Chloride	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Apr 26, 2016	Supplement 41Manufacturing · Standard review	Approved	None posted
Sep 15, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 20, 2015	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 7, 2015	Supplement 36Manufacturing · Standard review	Approved	None posted
Sep 8, 2014	Supplement 35Manufacturing · Standard review	Approved	Label
Feb 4, 2004	Supplement 23Labeling	Approved	None posted
Feb 4, 2004	Supplement 22Labeling	Approved	None posted
Jun 13, 2003	Supplement 21Labeling	Approved	None posted
Jul 1, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
May 15, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 7, 1993	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 26, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 29, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 29, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 18, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 13, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 21, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
May 5, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 21, 1988	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 25, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 4, 1988	Supplement 1Labeling	Approved	None posted
Mar 9, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19635
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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