US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 219357 (Dec 23, 2024)
Issued December 23, 2024
Issued
December 23, 2024
Application
NDA 505b1 • 219357
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due December 23, 2025Requires resubmission addressing deficiencies.
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