Vancomycin Hydrochloride

ANDA 62933, held by Hospira. Vancomycin Hydrochloride.

As of Nov 15, 2026, ANDA 62933 (Vancomycin Hydrochloride), held by Hospira, was first approved by FDA on Oct 29, 1992, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1992
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 29, 1992	Original application	Approved	None posted

Products

2 strengths and forms


Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection	Vancomycin Hydrochloride	Rx
Vancomycin HydrochlorideEQ 750MG BASE/VIAL · injectable;injection	Vancomycin Hydrochloride	Rx

All 19 submissions, including labeling and manufacturing supplements


May 24, 2021	Supplement 50Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 46Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 38Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 35Labeling · Standard review	Approved	None posted
Sep 1, 2020	Supplement 33Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 27Labeling	Approved	None posted
Jun 12, 2012	Supplement 32Labeling	Approved	Label
Nov 30, 2011	Supplement 21Labeling	Approved	Label
May 27, 2009	Supplement 20Labeling	Approved	None posted
Mar 15, 2002	Supplement 5Manufacturing	Approved	None posted
Feb 1, 2002	Supplement 9Manufacturing	Approved	None posted
Jun 14, 2001	Supplement 8Manufacturing	Approved	None posted
Apr 9, 2001	Supplement 7Manufacturing	Approved	None posted
Apr 4, 2000	Supplement 6Manufacturing	Approved	None posted
Nov 18, 1996	Supplement 4Manufacturing	Approved	None posted
Oct 25, 1995	Supplement 3Manufacturing	Approved	None posted
May 10, 1995	Supplement 2Manufacturing	Approved	None posted
Apr 9, 1993	Supplement 1Manufacturing	Approved	None posted
Oct 29, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 62933
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