Vancoled

ANDA 63321, held by Lederle. Vancomycin Hydrochloride.

As of Nov 15, 2026, ANDA 63321 (Vancoled), held by Lederle, was first approved by FDA on Oct 15, 1993, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 15, 1993
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
Oct 15, 1993	Original application	Approved	None posted

Products

2 strengths and forms


VancoledEQ 250MG BASE/5ML · for solution;oral	Vancomycin Hydrochloride	Discontinued
VancoledEQ 500MG BASE/6ML · for solution;oral	Vancomycin Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 29, 1999	Supplement 2Manufacturing	Approved	None posted
Aug 4, 1995	Supplement 1Manufacturing	Approved	None posted
Oct 15, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 63321
Drugs@FDA: Overview at FDA
Company: Lederle 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