NDA 219108, held by B Braun Medical. Rocuronium Bromide.
As of Nov 15, 2026, NDA 219108 (Rocuronium Bromide), held by B Braun Medical, was first approved by FDA on Oct 24, 2025, with 0 approved supplements 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 |
|---|---|---|---|
| Oct 24, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rocuronium Bromide50MG/5ML (10MG/ML) · solution;intravenous | Rocuronium Bromide | RxReference drug |
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
