Vecuronium Bromide

ANDA 74688, held by Meitheal. Vecuronium Bromide.

As of Nov 15, 2026, ANDA 74688 (Vecuronium Bromide), held by Meitheal, was first approved by FDA on Aug 25, 1999, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 25, 1999
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Vecuronium bromide for injection 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 7 submissions below

Date	Submission	Status	Documents
Aug 25, 1999	Original application	Approved	Letter

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Jul 26, 2018	Supplement 26Labeling · Standard review	Approved	None posted
Jan 30, 2012	Supplement 16Labeling	Approved	None posted
Nov 23, 2010	Supplement 10Labeling	Approved	None posted
May 12, 2009	Supplement 7Labeling	Approved	None posted
Jan 29, 2002	Supplement 2Labeling	Approved	None posted
Dec 5, 2000	Supplement 1Labeling	Approved	None posted
Aug 25, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 74688
Drugs@FDA: Overview at FDA
Company: Meitheal Pharmaceuticals

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