Sterile Water For Injection

NDA 18801, held by Hospira. Sterile Water For Injection.

As of Nov 13, 2026, NDA 18801 (Sterile Water For Injection), held by Hospira, was first approved by FDA on Oct 27, 1982, with 25 approved supplements and 0 published complete response letters.

First approved: Oct 27, 1982
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Oct 27, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms


Sterile Water For Injection100% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · liquid;n/a	Sterile Water For Injection	DiscontinuedReference drug
Sterile Water For Injection100% (10ML) · liquid;n/a	Sterile Water For Injection	RxReference drug
Sterile Water For Injection100% (20ML) · liquid;n/a	Sterile Water For Injection	RxReference drug
Sterile Water For Injection100% (50ML) · liquid;n/a	Sterile Water For Injection	RxReference drug
Sterile Water For Injection100% (100ML) · liquid;n/a	Sterile Water For Injection	RxReference drug
Sterile Water For Injection100% (5.2ML) · liquid;n/a	Sterile Water For Injection	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Dec 21, 2016	Supplement 40Manufacturing · Standard review	Approved	None posted
Mar 29, 2016	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 1, 2014	Supplement 36Manufacturing · Standard review	Approved	None posted
Jun 12, 2014	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 2, 2009	Supplement 34Manufacturing · Standard review	Approved	Letter
Apr 7, 2004	Supplement 23Manufacturing · Standard review	Approved	Letter
Feb 16, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 16, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
May 4, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 31, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
May 28, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
May 27, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 14, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
May 13, 1998	Supplement 13Labeling · Standard review	Approved	None posted
Jan 17, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 17, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 14, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 21, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 7, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 15, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 14, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 25, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 17, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 27, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18801
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