US FDA•United StatesAL•Approval Letter
Approval Letter Other (Nov 13, 2025)
Issued November 13, 2025
Issued
November 13, 2025
Application
Other
Review center
Other
Stage
Late Cycle
Letter type
Approval Letter
Response due November 13, 2026Product may be marketed.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.