US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 219045 (Oct 21, 2024)
Issued October 21, 2024
Issued
October 21, 2024
Application
NDA 505b1 • 219045
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due October 21, 2025Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.