ANDA 78651, held by Fresenius Kabi USA. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 78651 (Rocuronium Bromide), held by Fresenius Kabi USA, was first approved by FDA on Dec 29, 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 29, 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 |
|---|---|---|---|
| Aug 7, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 7, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 26, 2018 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 2, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 2, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 24, 2011 | Supplement 2Labeling | Approved | None posted |
| Dec 29, 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
