Tracrium Preservative Free, Tracrium

NDA 18831, held by Hospira. Atracurium Besylate.

As of Nov 14, 2026, NDA 18831 (Tracrium Preservative Free, Tracrium), held by Hospira, was first approved by FDA on Nov 23, 1983, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 23, 1983
Review: Priority
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Jun 6, 1994	Supplement 19Efficacy (new indication or use) · Priority review	Approved	None posted
Oct 29, 1986	Supplement 11Efficacy (new indication or use)	Approved	None posted
Feb 14, 1986	Supplement 8Efficacy (new indication or use)	Approved	None posted
Nov 23, 1983	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Tracrium Preservative Free10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Atracurium Besylate	DiscontinuedReference drug
Tracrium10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Atracurium Besylate	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 10Labeling	Approved	None posted
Mar 13, 2009	Supplement 6Labeling	Approved	None posted
Oct 3, 2000	Supplement 22Labeling · Standard review	Approved	None posted
Oct 3, 2000	Supplement 21Labeling · Standard review	Approved	None posted
Mar 26, 1999	Supplement 23Manufacturing · Priority review	Approved	None posted
Jun 8, 1995	Supplement 20Manufacturing · Priority review	Approved	None posted
Jun 6, 1994	Supplement 19Efficacy (new indication or use) · Priority review	Approved	None posted
Jun 1, 1994	Supplement 18Labeling · Standard review	Approved	None posted
Oct 6, 1992	Supplement 17Labeling · Standard review	Approved	None posted
Oct 6, 1992	Supplement 16Labeling	Approved	None posted
Jul 6, 1990	Supplement 15Labeling	Approved	None posted
May 19, 1989	Supplement 14Labeling	Approved	None posted
Dec 11, 1986	Supplement 13Labeling	Approved	None posted
Oct 29, 1986	Supplement 12Manufacturing · Priority review	Approved	None posted
Oct 29, 1986	Supplement 11Efficacy (new indication or use)	Approved	None posted
Oct 29, 1986	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 14, 1986	Supplement 8Efficacy (new indication or use)	Approved	None posted
Sep 11, 1985	Supplement 4Labeling	Approved	None posted
Jun 24, 1985	Supplement 5Labeling	Approved	None posted
Jun 20, 1985	Supplement 2Labeling	Approved	None posted
Jun 20, 1985	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 17, 1984	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 23, 1983	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18831
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