Vecuronium Bromide

ANDA 203725, held by Hikma. Vecuronium Bromide.

As of Nov 15, 2026, ANDA 203725 (Vecuronium Bromide), held by Hikma, was first approved by FDA on Jul 30, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 30, 2019
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (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 2 submissions below

Date	Submission	Status	Documents
Jul 30, 2019	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Dec 9, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Jul 30, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 203725
Drugs@FDA: Overview at FDA
Company: Hikma

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