NDA 217472, held by Fresenius Kabi USA. Rocuronium Bromide.
As of Nov 13, 2026, NDA 217472 (Rocuronium Bromide), held by Fresenius Kabi USA, was first approved by FDA on Jun 9, 2025, with 1 approved supplement and 0 published complete response letters.
Rocuronium Bromide Injection is 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 |
|---|---|---|---|
| Jun 9, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rocuronium Bromide50MG/5ML (10MG/ML) · solution;intravenous | Rocuronium Bromide | RxReference drug |
| Rocuronium Bromide100MG/10ML (10MG/ML) · solution;intravenous | Rocuronium Bromide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 15, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Jun 9, 2025 | Original applicationNew formulation or manufacturer · Standard review | 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
