Sodium Chloride 0.45% In Plastic Container

NDA 19759, held by Hospira. Sodium Chloride.

As of Nov 13, 2026, NDA 19759 (Sodium Chloride 0.45% In Plastic Container), held by Hospira, was first approved by FDA on Jun 8, 1988, with 31 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1988
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Jun 8, 1988	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 · injectable;injection	Sodium Chloride	Rx

All 32 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 29, 2019	Supplement 50Manufacturing	Approved	None posted
Dec 1, 2016	Supplement 47Labeling · Standard review	Approved	Letter Label
Jun 10, 2016	Supplement 46Labeling · Standard review	Approved	Letter
Nov 1, 2002	Supplement 32Manufacturing · Standard review	Approved	None posted
Apr 6, 2000	Supplement 31Manufacturing · Standard review	Approved	None posted
Apr 6, 2000	Supplement 30Labeling	Approved	None posted
Apr 6, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 2, 1999	Supplement 25Labeling	Approved	None posted
Dec 1, 1998	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 24, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
May 31, 1995	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 5, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 23, 1994	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 25, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 1, 1993	Supplement 8Labeling	Approved	None posted
Dec 1, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 16, 1993	Supplement 10Labeling	Approved	None posted
Jan 28, 1992	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 2, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 9, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 20, 1989	Supplement 2Labeling	Approved	None posted
Jul 18, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 6, 1988	Supplement 1Labeling	Approved	None posted
Jun 8, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19759
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