US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 217719 (Mar 10, 2025)
Issued March 10, 2025
Issued
March 10, 2025
Application
NDA 505b1 • 217719
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due March 10, 2026Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.