Vancomycin Hydrochloride

ANDA 202464, held by Avet Lifesciences. Vancomycin Hydrochloride.

As of Nov 15, 2026, ANDA 202464 (Vancomycin Hydrochloride), held by Avet Lifesciences, was first approved by FDA on Oct 9, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 9, 2013
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 9, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vancomycin HydrochlorideEQ 10GM BASE/VIAL · injectable;injection	Vancomycin Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


May 25, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Sep 22, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 22, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Oct 9, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202464
Drugs@FDA: Overview at FDA
Company: Avet Lifesciences

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