CRLComplete Response Letter
Complete Response Letter Hikma Pharmaceuticals USA Inc. (Feb 28, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Device constituent and human factors, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Issued
US FDA• KLOXXADO
