Nimbex, Nimbex Preservative Free

NDA 20551, held by Abbvie. Cisatracurium Besylate.

As of Nov 13, 2026, NDA 20551 (Nimbex, Nimbex Preservative Free), held by Abbvie, was first approved by FDA on Dec 15, 1995, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1995
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Jul 18, 2003	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 15, 1998	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 15, 1995	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

3 strengths and forms


NimbexEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Cisatracurium Besylate	DiscontinuedReference drug
Nimbex Preservative FreeEQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Cisatracurium Besylate	DiscontinuedReference drug
Nimbex Preservative FreeEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Cisatracurium Besylate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Oct 14, 2022	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 7, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Jul 26, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 26, 2018	Supplement 20Labeling · Standard review	Approved	Letter Label
Apr 1, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 22, 2010	Supplement 19Labeling	Approved	Letter Label
Jun 2, 2010	Supplement 17Labeling · Standard review	Approved	Letter
Jul 18, 2003	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 15, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 4, 2002	Supplement 10Manufacturing · Standard review	Approved	Letter
Feb 25, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Feb 25, 2000	Supplement 7Labeling · Standard review	Approved	None posted
May 21, 1999	Supplement 5Labeling · Standard review	Approved	None posted
May 21, 1999	Supplement 4Labeling · Standard review	Approved	None posted
Mar 26, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 15, 1998	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 19, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Dec 15, 1995	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 20551
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