FDA letter monthly archive

FDA Letters Issued in May 2016

Name: FDA Letters Issued in May 2016
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in May 2016. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals, Inc. (May 27, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 27, 2016
US FDA• AUSTEDO
CRLComplete Response Letter
Complete Response Letter Scilex Pharmaceuticals, Inc. (May 10, 2016)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 10, 2016
US FDA• ZTLIDO
CRLComplete Response Letter
Complete Response Letter 3M Health Care (Infection Prevention Division) (May 6, 2016)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 6, 2016
US FDA• SOLUPREP S

Complete Response Letter Teva Pharmaceuticals, Inc. (May 27, 2016)

Complete Response Letter Scilex Pharmaceuticals, Inc. (May 10, 2016)

Complete Response Letter 3M Health Care (Infection Prevention Division) (May 6, 2016)