Rocuronium Bromide

ANDA 79199, held by Mylan Institutional. Rocuronium Bromide.

As of Nov 13, 2026, ANDA 79199 (Rocuronium Bromide), held by Mylan Institutional, was first approved by FDA on Nov 26, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2008
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 26, 2008	Original application	Approved	Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Rocuronium Bromide50MG/5ML (10MG/ML) · injectable;injection	Rocuronium Bromide	Rx
Rocuronium Bromide100MG/10ML (10MG/ML) · injectable;injection	Rocuronium Bromide	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Jul 26, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Nov 12, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Nov 21, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Jul 20, 2012	Supplement 4Labeling · Standard review	Approved	None posted
May 24, 2011	Supplement 1Labeling	Approved	None posted
Nov 26, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 79199
Drugs@FDA: Overview at FDA
Company: Mylan Institutional

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