FDAsafety guidance83% confidence
FDA AP — MYCOPHENOLATE SODIUM (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to pilonidal sinus disease treatments.
Regulatory Analysis
Application ANDA214376. Sponsor: YICHANG HUMANWELL. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: MYCOPHENOLATE SODIUM.
Supporting Context
- Therapeutic area
- Surgery · Pilonidal Sinus Disease
- Sub-indication
- General
Related signal: Trial Compares Laser Ablation vs Crystallized Phenol for Pilonidal Sinus Disease