Rocuronium Bromide

ANDA 78717, held by Teva Pharms. Rocuronium Bromide.

As of Nov 13, 2026, ANDA 78717 (Rocuronium Bromide), held by Teva Pharms, was first approved by FDA on Nov 26, 2008, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2008
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

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

Products

2 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Jul 26, 2018	Supplement 21Labeling · Standard review	Approved	None posted
Oct 26, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Jul 17, 2012	Supplement 11Labeling · Standard review	Approved	None posted
Jan 31, 2012	Supplement 10Labeling	Approved	None posted
Nov 26, 2008	Original application	Approved	Label Letter

Identifiers

Application: ANDA 78717
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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