FDA letter monthly archive

FDA Letters Issued in October 2014

Name: FDA Letters Issued in October 2014
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in October 2014. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Mylan Pharmaceuticals Inc. (Oct 23, 2014)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 23, 2014
US FDA• ABACAVIR SULFATE AND LAMIVUDINE

Complete Response Letter Mylan Pharmaceuticals Inc. (Oct 23, 2014)