US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 218828 (Dec 19, 2024)
Issued December 19, 2024
Issued
December 19, 2024
Application
NDA 505b1 • 218828
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due December 19, 2025Requires resubmission addressing deficiencies.
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