Vecuronium Bromide

ANDA 75164, held by Hospira. Vecuronium Bromide.

As of Nov 15, 2026, ANDA 75164 (Vecuronium Bromide), held by Hospira, was first approved by FDA on Oct 21, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1999
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
Oct 21, 1999	Original application	Approved	Letter Review

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 14Labeling · Standard review	Approved	None posted
Oct 16, 2012	Supplement 11Labeling · Standard review	Approved	None posted
Nov 23, 2010	Supplement 10Labeling	Approved	None posted
May 12, 2009	Supplement 8Labeling	Approved	None posted
Oct 21, 1999	Original application	Approved	Letter Review

Identifiers

Application: ANDA 75164
Drugs@FDA: Overview at FDA
Company: Hospira

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