US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 218345 (Jul 1, 2024)
Issued July 1, 2024
Issued
July 1, 2024
Application
NDA 505b1 • 218345
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Requires resubmission addressing deficiencies.
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