Vecuronium Bromide

ANDA 75218, held by Hikma. Vecuronium Bromide.

As of Nov 15, 2026, ANDA 75218 (Vecuronium Bromide), held by Hikma, was first approved by FDA on Aug 23, 1999, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 23, 1999
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 23, 1999	Original application	Approved	Other Letter Letter

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jul 26, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Nov 22, 2011	Supplement 2Labeling	Approved	None posted
Apr 20, 2001	Supplement 1Labeling	Approved	None posted
Aug 23, 1999	Original application	Approved	Other Letter Letter

Identifiers

Application: ANDA 75218
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