ANDA 79195, held by Sandoz. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 79195 (Rocuronium Bromide), held by Sandoz, was first approved by FDA on Dec 5, 2008, with 6 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 |
|---|---|---|---|
| Dec 5, 2008 | Original application | Approved | None posted |
| 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 |
|---|---|---|---|
| Jun 20, 2023 | Supplement 22Labeling · Standard review | Approved | None posted |
| May 3, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 26, 2018 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 16, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 12, 2013 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 24, 2011 | Supplement 3Labeling | Approved | None posted |
| Dec 5, 2008 | Original application | Approved | None posted |
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
