US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 218353 (Apr 25, 2025)
Issued April 25, 2025
Issued
April 25, 2025
Application
NDA 505b1 • 218353
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due April 25, 2026Requires resubmission addressing deficiencies.
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