Sodium Chloride 0.45% In Plastic Container

NDA 18184, held by B Braun. Sodium Chloride.

As of Nov 13, 2026, NDA 18184 (Sodium Chloride 0.45% In Plastic Container), held by B Braun, was first approved by FDA on Jun 8, 1979, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1979
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jun 8, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Chloride 0.45% In Plastic Container450MG/100ML · injectable;injection	Sodium Chloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Dec 2, 1991	Supplement 15Labeling	Approved	None posted
Sep 11, 1990	Supplement 14Manufacturing	Approved	None posted
Dec 30, 1987	Supplement 12Manufacturing	Approved	None posted
Feb 18, 1986	Supplement 8Manufacturing	Approved	None posted
Jun 28, 1985	Supplement 9Manufacturing	Approved	None posted
Jun 4, 1985	Supplement 11Labeling	Approved	None posted
Apr 3, 1985	Supplement 10Manufacturing	Approved	None posted
Jan 24, 1983	Supplement 6Labeling	Approved	None posted
Oct 26, 1981	Supplement 7Manufacturing	Approved	None posted
Oct 24, 1980	Supplement 5Manufacturing	Approved	None posted
Aug 6, 1980	Supplement 4Manufacturing	Approved	None posted
Feb 12, 1980	Supplement 3Manufacturing	Approved	None posted
Oct 16, 1979	Supplement 2Labeling	Approved	None posted
Oct 16, 1979	Supplement 1Manufacturing	Approved	None posted
Jun 8, 1979	Original application	Approved	None posted

Identifiers

Application: NDA 18184
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