US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 205508 (Jul 28, 2025)
Issued July 28, 2025
Issued
July 28, 2025
Application
NDA 505b1 • 205508
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due July 28, 2026Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.