Bacteriostatic Water For Injection In Plastic Container

NDA 18802, held by Hospira. Sterile Water For Injection.

As of Nov 13, 2026, NDA 18802 (Bacteriostatic Water For Injection In Plastic Container), held by Hospira, was first approved by FDA on Oct 27, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 27, 1982
Review: Standard
Supplements approved: 14
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 15 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bacteriostatic Water For Injection In Plastic Container100% · liquid;n/a	Sterile Water For Injection	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 26, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 12, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 15, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Jun 23, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 19, 1997	Supplement 10Labeling · Standard review	Approved	None posted
Sep 30, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 23, 1988	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 18802
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