Vancomycin Hydrochloride In Plastic Container

NDA 50671, held by Baxter Hlthcare. Vancomycin Hydrochloride.

As of Nov 14, 2026, NDA 50671 (Vancomycin Hydrochloride In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Apr 29, 1993, with 18 approved supplements and 0 published complete response letters.

First approved: Apr 29, 1993
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved:

Septicemia
Infective Endocarditis
Skin and Skin Structure Infections
Bone Infections
Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jan 8, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Apr 29, 1993	Original applicationNew dosage form · Standard review	Approved	Label

Products

5 strengths and forms


Vancomycin Hydrochloride In Plastic ContainerEQ 500MG BASE/100ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
Vancomycin Hydrochloride In Plastic ContainerEQ 750MG BASE/150ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
Vancomycin Hydrochloride In Plastic ContainerEQ 1GM BASE/200ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
Vancomycin Hydrochloride In Plastic ContainerEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
Vancomycin Hydrochloride In Plastic ContainerEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jun 9, 2026	Supplement 43Labeling · Standard review	Approved	Label Letter
May 29, 2025	Supplement 36Labeling · Standard review	Approved	Letter Label
Jun 7, 2024	Supplement 32Labeling · Standard review	Approved	Letter Label
Jan 29, 2021	Supplement 31Labeling · Standard review	Approved	Label Letter
Sep 28, 2017	Supplement 24Labeling · Standard review	Approved	Label Letter
Jan 9, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Dec 18, 2015	Supplement 22Manufacturing · Standard review	Approved	Label Letter
Nov 13, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 17, 2012	Supplement 18Labeling	Approved	Label Letter
Mar 11, 2009	Supplement 14Labeling · Standard review	Approved	Label Letter
May 2, 2008	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 17, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Mar 30, 2004	Supplement 6Labeling · Standard review	Approved	Letter Label
Mar 1, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 8, 1998	Supplement 4Labeling · Standard review	Approved	Review
Jan 8, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Nov 7, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 30, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 29, 1993	Original applicationNew dosage form · Standard review	Approved	Label

Identifiers

Application: NDA 50671
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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