US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 219029 (May 29, 2025)
Issued May 29, 2025
Issued
May 29, 2025
Application
NDA 505b1 • 219029
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Requires resubmission addressing deficiencies.
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