US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 218879 (Jan 3, 2025)
Issued January 3, 2025
Issued
January 3, 2025
Application
NDA 505b1 • 218879
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due January 3, 2026Requires resubmission addressing deficiencies.
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