CRLComplete Response Letter
Complete Response Letter Armstrong Pharmaceuticals (May 22, 2014)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Safety and adverse events, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Issued
US FDA• PRIMATENE MIST
