US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 216195 (Jul 25, 2024)
Issued July 25, 2024
Issued
July 25, 2024
Application
NDA 505b1 • 216195
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due July 25, 2025Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.