FDAsafety guidance72% confidence
FDA AP — ROCURONIUM BROMIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Hyoscine Butyl Bromide.
Regulatory Analysis
Application NDA217472. Sponsor: FRESENIUS KABI USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ROCURONIUM BROMIDE.
Supporting Context
- Therapeutic area
- Obstetrics · Labor Induction
- Sub-indication
- General
Related signal: Study on Hyoscine Butyl Bromide and Prostaglandins for Labor Induction