Vecuronium Bromide

ANDA 75549, held by Hikma. Vecuronium Bromide.

As of Nov 15, 2026, ANDA 75549 (Vecuronium Bromide), held by Hikma, was first approved by FDA on Jun 13, 2000, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 13, 2000
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 13, 2000	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 5 submissions, including labeling and manufacturing supplements


Jul 26, 2018	Supplement 13Labeling · Standard review	Approved	Label
Nov 23, 2010	Supplement 9Labeling	Approved	Label
Mar 1, 2007	Supplement 7Labeling	Approved	None posted
Feb 26, 2001	Supplement 1Labeling	Approved	None posted
Jun 13, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75549
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