Vancomycin Hydrochloride

ANDA 90439, held by Lupin. Vancomycin Hydrochloride.

As of Nov 15, 2026, ANDA 90439 (Vancomycin Hydrochloride), held by Lupin, was first approved by FDA on Jan 28, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2015
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 28, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Vancomycin HydrochlorideEQ 125MG BASE · capsule;oral	Vancomycin Hydrochloride	Discontinued
Vancomycin HydrochlorideEQ 250MG BASE · capsule;oral	Vancomycin Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 3, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Nov 3, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Nov 3, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Nov 3, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Nov 3, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Jan 28, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 90439
Drugs@FDA: Overview at FDA
Company: Lupin

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