Mivacron, Mivacron In Dextrose 5% In Plastic Container

NDA 20098, held by Abbvie. Mivacurium Chloride.

As of Nov 14, 2026, NDA 20098 (Mivacron, Mivacron In Dextrose 5% In Plastic Container), held by Abbvie, was first approved by FDA on Jan 22, 1992, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 22, 1992
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jan 22, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

5 strengths and forms


MivacronEQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intravenous	Mivacurium Chloride	DiscontinuedReference drug
Mivacron In Dextrose 5% In Plastic ContainerEQ 0.5MG BASE/ML · injectable;injection	Mivacurium Chloride	Discontinued
Mivacron In Dextrose 5% In Plastic ContainerEQ 50MG BASE/100ML · injectable;injection	Mivacurium Chloride	Discontinued
MivacronEQ 10MG BASE/5ML (EQ 2MG BASE/ML) · solution;intravenous	Mivacurium Chloride	DiscontinuedReference drug
MivacronEQ 20MG BASE/10ML (EQ 2MG BASE/ML) · solution;intravenous	Mivacurium Chloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jul 26, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 30, 2015	Supplement 18Manufacturing · Priority review	Approved	Label
Nov 22, 2010	Supplement 17Labeling	Approved	Letter Label
Oct 15, 2002	Supplement 14Manufacturing · Priority review	Approved	None posted
Jun 4, 2002	Supplement 13Manufacturing · Priority review	Approved	Letter
Feb 20, 2001	Supplement 12Labeling · Standard review	Approved	None posted
Jun 25, 1999	Supplement 10Labeling · Standard review	Approved	None posted
Mar 17, 1999	Supplement 11Manufacturing · Priority review	Approved	None posted
May 19, 1998	Supplement 9Labeling · Standard review	Approved	Letter Label Review
Jun 4, 1997	Supplement 8Manufacturing · Priority review	Approved	None posted
Jun 9, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Feb 8, 1995	Supplement 1Labeling · Standard review	Approved	None posted
Aug 18, 1994	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 15, 1994	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 2, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Jan 25, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Jan 22, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20098
Drugs@FDA: Overview at FDA
Company: AbbVie

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