US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 220049 (Aug 18, 2025)
Issued August 18, 2025
Issued
August 18, 2025
Application
NDA 505b1 • 220049
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due August 18, 2026Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.