US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter NDA 505b1 215455 (Aug 8, 2024)
Issued August 8, 2024
Issued
August 8, 2024
Application
NDA 505b1 • 215455
Review center
CDER
Stage
Final Decision
Letter type
Complete Response Letter
Response due November 6, 2024Requires resubmission addressing deficiencies.
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