Sold as Zemuron, Rocuronium Bromide. Every FDA application for this active ingredient: 3 branded and 22 generic.
As of Nov 13, 2026, FDA lists 25 applications for Rocuronium Bromide (sold as Zemuron, Rocuronium Bromide), first approved Mar 17, 1994, with 1 new use approved and 0 published complete response letters.
| Shortage | Status | First posted | Updated |
|---|---|---|---|
| Rocuronium Bromide Injection | Current | Feb 15, 2023 | Nov 10, 2026 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor SurgerySpinal Cord Neoplasms, Spinal Neoplasms · Beijing Tsinghua Chang Gung Hospital | Phase 4 | Not yet recruiting | Oct 28, 2026 |
| Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway InsertionAirway Management, Supraglottic Airway Device Insertion · Hacettepe University | Phase 4 | Not yet recruiting | Oct 26, 2026 |
| Boyle-Davis Mouth Gag Timing in Pediatric Tonsil SurgeryTonsillectomy and Adenotonsillectomy in Children · Yahyali State Hospital | Not applicable | Not yet recruiting | Oct 22, 2026 |
| Propofol or Esketamine: Tracheal Intubation ComparisonCritically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Phase 4 | Not yet recruiting | Sep 29, 2026 |
| Epidural Versus General Anesthesia for Laparoscopic HysterectomyAnesthesia for Laparoscopic Hysterectomy · Sabiha Başarı | Not applicable | Not yet recruiting | Sep 29, 2026 |
| INtubation With Sedation Only to Preserve Independent Respiratory Effort TrialAcute Respiratory Failure · Vanderbilt University Medical Center | Not applicable | Enrolling by invitation | Sep 28, 2026 |
| Effect of Muscle Relaxants on Postoperative Sore Throat in Video Laryngeal Mask Airway(LMA) UseLaryngeal Mask Airway · Samsun University | — | Recruiting | Sep 24, 2026 |
| REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential MonitoringAirway Management, Endotracheal Intubation · Mayo Clinic | Phase 4 | Not yet recruiting | Sep 22, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 17, 1994 | ZemuronNDA 20214 · New molecular entity | Organon USA Inc | 20 | Discontinued |
| Nov 26, 2008 | Rocuronium BromideANDA 78519 | Hospira | 7 | Marketed |
| Nov 26, 2008 | Rocuronium BromideANDA 78717 | Teva Pharms | 5 | Discontinued |
| Nov 26, 2008 | Rocuronium BromideANDA 79199 | Mylan Institutional | 7 | Marketed |
| Dec 5, 2008 | Rocuronium BromideANDA 79195 | Sandoz | 6 | Marketed |
| Dec 29, 2008 | Rocuronium BromideANDA 78651 | Fresenius Kabi USA | 6 | Marketed |
| Jul 28, 2010 | Rocuronium BromideANDA 91458 | Sagent Pharms Inc | 5 | Marketed |
| Aug 27, 2012 | Rocuronium BromideANDA 91115 | Tamarang | 2 | Marketed |
| Feb 28, 2017 | Rocuronium BromideANDA 204679 | West Ward Pharm Corp | 3 | Marketed |
| Apr 12, 2017 | Rocuronium BromideANDA 206206 | Eugia Pharma | 2 | Marketed |
| Apr 4, 2018 | Rocuronium BromideANDA 205656 | Gland | 2 | Marketed |
| Aug 13, 2019 | Rocuronium BromideANDA 210437 | Piramal Critical | 0 | Marketed |
| May 26, 2022 | Rocuronium BromideANDA 212668 | Prinston | 0 | Marketed |
| Mar 2, 2023 | Rocuronium BromideANDA 216234 | Caplin | 0 | Marketed |
| May 8, 2023 | Rocuronium BromideANDA 213453 | Meitheal | 0 | Marketed |
| May 24, 2023 | Rocuronium BromideANDA 217034 | Hikma | 0 | Discontinued |
| Jul 12, 2024 | Rocuronium BromideANDA 204918 | Rising | 0 | Discontinued |
| Jul 12, 2024 | Rocuronium BromideANDA 215684 | Shandong | 0 | Marketed |
| Jul 22, 2024 | Rocuronium BromideANDA 217092 | Steriscience | 0 | Marketed |
| May 29, 2025 | Rocuronium BromideANDA 219674 | Mankind Pharma | 0 | Marketed |
| Jun 9, 2025 | Rocuronium BromideNDA 217472 · New formulation or manufacturer | Fresenius Kabi USA | 1 | Marketed |
| Oct 24, 2025 | Rocuronium BromideNDA 219108 · New formulation or manufacturer | B Braun Medical | 0 | Marketed |
| Jan 6, 2026 | Rocuronium BromideANDA 213476 | Knack | 0 | Discontinued |
| Mar 4, 2026 | Rocuronium BromideANDA 220124 | Aspiro | 0 | Marketed |
| Sep 18, 2026 | Rocuronium BromideANDA 219260 | Baxter Hlthcare Corp | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sandoz