FDA letter monthly archive

FDA Letters Issued in November 2018

Name: FDA Letters Issued in November 2018
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in November 2018. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Innocoll Pharmaceuticals (Nov 30, 2018)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, 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.
IssuedNov 30, 2018
US FDA• XARACOLL
CRLComplete Response Letter
Complete Response Letter Valeant Pharmaceuticals Ireland (Nov 20, 2018)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 20, 2018
US FDA• TETRACAINE HYDROCHLORIDE
CRLComplete Response Letter
Complete Response Letter Trevena, Inc. (Nov 2, 2018)
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, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 2, 2018
US FDA• OLINVYK

Complete Response Letter Innocoll Pharmaceuticals (Nov 30, 2018)

Complete Response Letter Valeant Pharmaceuticals Ireland (Nov 20, 2018)

Complete Response Letter Trevena, Inc. (Nov 2, 2018)