FDA letter monthly archive

FDA Letters in June 2018

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

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

CRLComplete Response Letter
Complete Response Letter Actavis LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals U.S.A. Inc. (Jun 26, 2018)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 26, 2018
US FDA• PEMETREXED
CRLComplete Response Letter
Complete Response Letter Dow Pharmaceutical Sciences, Inc. (Jun 15, 2018)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Bioequivalence and pharmacokinetics, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 15, 2018
US FDA• DUOBRII

Complete Response Letter Actavis LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals U.S.A. Inc. (Jun 26, 2018)

Complete Response Letter Dow Pharmaceutical Sciences, Inc. (Jun 15, 2018)