Sodium Chloride 0.45% In Plastic Container

NDA 18380, held by Hospira. Sodium Chloride.

As of Nov 14, 2026, NDA 18380 (Sodium Chloride 0.45% In Plastic Container), held by Hospira, was first approved by FDA on Aug 5, 1980, with 35 approved supplements and 0 published complete response letters.

First approved: Aug 5, 1980
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Aug 5, 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 36 submissions, including labeling and manufacturing supplements


Aug 21, 1997	Supplement 43Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 42Manufacturing · Standard review	Approved	None posted
Mar 28, 1997	Supplement 41Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 40Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 38Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 33Manufacturing · Standard review	Approved	None posted
Aug 30, 1991	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 14, 1989	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 6, 1989	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 30, 1987	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 25, 1986	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 21, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 26, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 17, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 22, 1984	Supplement 12Labeling · Standard review	Approved	None posted
Sep 22, 1984	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 21, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 31, 1982	Supplement 2Labeling · Standard review	Approved	None posted
Jul 26, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 9, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 1, 1982	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 16, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 29, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 22, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 19, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 5, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18380
Drugs@FDA: Overview at FDA
Company: Hospira

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