Vecuronium Bromide

ANDA 90243, held by Mylan Labs Ltd. Vecuronium Bromide.

As of Nov 15, 2026, ANDA 90243 (Vecuronium Bromide), held by Mylan Labs Ltd, was first approved by FDA on May 11, 2010, with 2 approved supplements and 0 published complete response letters.

First approved: May 11, 2010
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
May 11, 2010	Original application	Approved	Other

Products

2 strengths and forms


Vecuronium Bromide10MG/VIAL · injectable;injection	Vecuronium Bromide	Rx
Vecuronium Bromide20MG/VIAL · injectable;injection	Vecuronium Bromide	Rx

All 3 submissions, including labeling and manufacturing supplements


Jul 26, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Nov 23, 2010	Supplement 1Labeling	Approved	None posted
May 11, 2010	Original application	Approved	Other

Identifiers

Application: ANDA 90243
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