FDA letter monthly archive

FDA Letters Issued in November 2020

Name: FDA Letters Issued in November 2020
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in November 2020. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Zhejiang Novus Pharmaceuticals Co. Ltd. (Nov 27, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 27, 2020
US FDA• VANCOMYCIN HYDROCHLORIDE
CRLComplete Response Letter
Complete Response Letter Genentech, Incorporated (Nov 23, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 23, 2020
US FDA• XOFLUZA
CRLComplete Response Letter
Complete Response Letter Adamis Pharmaceuticals Corporation (Nov 13, 2020)
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, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 13, 2020
US FDA• ZIMHI
CRLComplete Response Letter
Complete Response Letter Alkermes, Inc. (Nov 13, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 13, 2020
US FDA• LYBALVI
CRLComplete Response Letter
Complete Response Letter Bioverativ USA, Inc. (Nov 13, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 13, 2020
US FDA• ENJAYMO
CRLComplete Response Letter
Complete Response Letter sanofi-aventis U.S. LLC (Nov 12, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 12, 2020
US FDA• FEXINIDAZOLE
CRLComplete Response Letter
Complete Response Letter Supernus Pharmaceuticals, Inc. (Nov 6, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 6, 2020
US FDA• QELBREE

Complete Response Letter Zhejiang Novus Pharmaceuticals Co. Ltd. (Nov 27, 2020)

Complete Response Letter Genentech, Incorporated (Nov 23, 2020)

Complete Response Letter Adamis Pharmaceuticals Corporation (Nov 13, 2020)

Complete Response Letter Alkermes, Inc. (Nov 13, 2020)

Complete Response Letter Bioverativ USA, Inc. (Nov 13, 2020)

Complete Response Letter sanofi-aventis U.S. LLC (Nov 12, 2020)

Complete Response Letter Supernus Pharmaceuticals, Inc. (Nov 6, 2020)