Vancomycin Hydrochloride

Treats serious or severe infections caused by susceptible strains of…. ANDA 63076, held by Hospira. Vancomycin Hydrochloride.

As of Nov 15, 2026, ANDA 63076 (Vancomycin Hydrochloride), held by Hospira, was first approved by FDA on Dec 21, 1990, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1990
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 21, 1990	Original application	Approved	None posted

Products

2 strengths and forms


Vancomycin HydrochlorideEQ 5GM BASE/VIAL · injectable;injection	Vancomycin Hydrochloride	Rx
Vancomycin HydrochlorideEQ 10GM BASE/VIAL · injectable;injection	Vancomycin Hydrochloride	Rx

All 14 submissions, including labeling and manufacturing supplements


May 24, 2021	Supplement 43Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 39Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 27Labeling · Standard review	Approved	None posted
May 22, 2012	Supplement 25Labeling	Approved	Label
Nov 30, 2011	Supplement 18Labeling	Approved	None posted
Jul 25, 2005	Supplement 10Labeling	Approved	None posted
Oct 4, 2002	Supplement 7Manufacturing	Approved	None posted
Feb 1, 2002	Supplement 6Manufacturing	Approved	None posted
Jun 14, 2001	Supplement 5Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 4Manufacturing	Approved	None posted
Nov 18, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 25, 1995	Supplement 2Manufacturing	Approved	None posted
Dec 21, 1990	Original application	Approved	None posted

Identifiers

Application: ANDA 63076
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