Rocuronium Bromide

ANDA 91458, held by Sagent Pharms Inc. Rocuronium Bromide.

As of Nov 13, 2026, ANDA 91458 (Rocuronium Bromide), held by Sagent Pharms Inc, was first approved by FDA on Jul 28, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 28, 2010
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
Jul 28, 2010	Original application	Approved	None posted

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 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 25, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jul 26, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Oct 16, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 16, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Sep 27, 2011	Supplement 1Labeling	Approved	None posted
Jul 28, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91458
Drugs@FDA: Overview at FDA
Company: Sagent 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