ANDA 78519, held by Hospira. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 78519 (Rocuronium Bromide), held by Hospira, was first approved by FDA on Nov 26, 2008, with 7 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 2008 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rocuronium Bromide50MG/5ML (10MG/ML) · injectable;injection | Rocuronium Bromide | Rx |
| Rocuronium Bromide100MG/10ML (10MG/ML) · injectable;injection | Rocuronium Bromide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2020 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jul 26, 2018 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jul 19, 2018 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 13, 2013 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 24, 2011 | Supplement 5Labeling | Approved | None posted |
| Jun 15, 2010 | Supplement 4Labeling | Approved | None posted |
| Jan 12, 2010 | Supplement 3Labeling | Approved | None posted |
| Nov 26, 2008 | Original application | Approved |
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
