Sterile Water For Injection In Plastic Container

NDA 19633, held by B Braun. Sterile Water For Injection.

As of Nov 13, 2026, NDA 19633 (Sterile Water For Injection In Plastic Container), held by B Braun, was first approved by FDA on Feb 29, 1988, with 17 approved supplements and 0 published complete response letters.

First approved: Feb 29, 1988
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Feb 29, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 18 submissions, including labeling and manufacturing supplements


Aug 29, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
May 5, 2003	Supplement 19Labeling	Approved	None posted
Jul 1, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
May 15, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 26, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 29, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 18, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 13, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 21, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
May 5, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 21, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 28, 1988	Supplement 1Labeling	Approved	None posted
Feb 29, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19633
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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