Zemuron

NDA 20214, held by Organon USA Inc. Rocuronium Bromide.

As of Nov 13, 2026, NDA 20214 (Zemuron), held by Organon USA Inc, was first approved by FDA on Mar 17, 1994, with 20 approved supplements and 0 published complete response letters.

First approved: Mar 17, 1994
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Aug 28, 2008	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Written Request Pediatric Medical Review
Mar 17, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Zemuron50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Rocuronium Bromide	DiscontinuedReference drug
Zemuron10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Rocuronium Bromide	DiscontinuedReference drug
Zemuron100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Rocuronium Bromide	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Jul 26, 2018	Supplement 38Labeling · Standard review	Approved	Letter Label
Jan 6, 2015	Supplement 36Labeling · Standard review	Approved	Letter Label
Apr 29, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Nov 22, 2010	Supplement 34Labeling	Approved	Letter Label
Aug 28, 2008	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Written Request Pediatric Medical Review
Aug 18, 2004	Supplement 21Labeling · Standard review	Approved	Letter
Feb 6, 2004	Supplement 16Labeling · Standard review	Approved	Letter
Jun 4, 2003	Supplement 17Labeling · Standard review	Approved	Letter
Jul 20, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 5, 2001	Supplement 13Labeling · Standard review	Approved	None posted
Mar 27, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Mar 27, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Mar 17, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 3, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 30, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 25, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 21, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 4, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 7, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Nov 22, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 17, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20214
Drugs@FDA: Overview at FDA
Company: Organon USA

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