Sodium Chloride 0.9% In Plastic Container

NDA 19480, held by Hospira. Sodium Chloride.

As of Nov 13, 2026, NDA 19480 (Sodium Chloride 0.9% In Plastic Container), held by Hospira, was first approved by FDA on Sep 17, 1985, with 29 approved supplements and 0 published complete response letters.

First approved: Sep 17, 1985
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Sep 17, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Chloride 0.9% In Plastic Container900MG/100ML · injectable;injection	Sodium Chloride	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


May 29, 2019	Supplement 49Manufacturing	Approved	None posted
Sep 27, 2016	Supplement 46Labeling · Standard review	Approved	Label Letter
Jun 10, 2016	Supplement 45Labeling · Standard review	Approved	Letter
Nov 1, 2002	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 2, 1999	Supplement 29Labeling	Approved	None posted
Dec 1, 1998	Supplement 32Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 30Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 24, 1996	Supplement 25Manufacturing · Standard review	Approved	None posted
May 31, 1995	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 5, 1995	Supplement 23Manufacturing · Standard review	Approved	None posted
Sep 23, 1994	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 25, 1994	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 2, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 9, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 20, 1989	Supplement 8Labeling	Approved	None posted
Aug 3, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 18, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 6, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 17, 1986	Supplement 1Labeling	Approved	None posted
Sep 17, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19480
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