FDA letter monthly archive

FDA Letters Issued in July 2024

Name: FDA Letters Issued in July 2024
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in July 2024. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter RB Health (US) LLC (Jul 26, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial 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.
IssuedJul 26, 2024
US FDA• MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
CRLComplete Response Letter
Complete Response Letter Xspray Pharma AB (Jul 25, 2024)
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.
IssuedJul 25, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Orexo AB (Jul 15, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 15, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter MEDRx USA, Inc. (Jul 11, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 11, 2024
US FDA• BONDLIDO
CRLComplete Response Letter
Complete Response Letter Novo Nordisk Inc. (Jul 10, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, 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.
IssuedJul 10, 2024
US FDA• AWIQLI FLEXTOUCH
CRLComplete Response Letter
Complete Response Letter Samsung Bioepis Co., Ltd. (Jul 4, 2024)
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.
IssuedJul 4, 2024
US FDA• PYZCHIVA
CRLComplete Response Letter
Complete Response Letter Amneal EU, Ltd. (Jul 1, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 1, 2024
US FDA• Unknown

Complete Response Letter RB Health (US) LLC (Jul 26, 2024)

Complete Response Letter Xspray Pharma AB (Jul 25, 2024)

Complete Response Letter Orexo AB (Jul 15, 2024)

Complete Response Letter MEDRx USA, Inc. (Jul 11, 2024)

Complete Response Letter Novo Nordisk Inc. (Jul 10, 2024)

Complete Response Letter Samsung Bioepis Co., Ltd. (Jul 4, 2024)

Complete Response Letter Amneal EU, Ltd. (Jul 1, 2024)