Vancomycin Hydrochloride

ANDA 91469, held by Mylan Labs Ltd. Vancomycin Hydrochloride.

As of Nov 15, 2026, ANDA 91469 (Vancomycin Hydrochloride), held by Mylan Labs Ltd, was first approved by FDA on Jul 1, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 1, 2011	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 3 submissions, including labeling and manufacturing supplements


Aug 27, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Jan 15, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Jul 1, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91469
Drugs@FDA: Overview at FDA
Company: Mylan Laboratories

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