FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,819 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 217-228 of 1819 letters

CRLComplete Response Letter
Complete Response Letter HQ Specialty Pharma Corporation (Sep 14, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 14, 2021
US FDA• MEROPENEM
CRLComplete Response Letter
Complete Response Letter CellTrans Inc. (Aug 18, 2021)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, 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.
IssuedAug 18, 2021
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Kashiv BioSciences, LLC (Aug 11, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 11, 2021
US FDA• FYLNETRA
CRLComplete Response Letter
Complete Response Letter LLC (Aug 5, 2021)
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.
IssuedAug 5, 2021
US FDA• LIQREV
CRLComplete Response Letter
Complete Response Letter Spectrum Pharmaceuticals, Inc. (Aug 3, 2021)
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.
IssuedAug 3, 2021
US FDA• ROLVEDON
CRLComplete Response Letter
Complete Response Letter Kashiv BioSciences, LLC (Aug 2, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 2, 2021
US FDA• RELEUKO
CRLComplete Response Letter
Complete Response Letter medac Gesellschaft fur klinische Spezialpraparate mbH (Jul 30, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 30, 2021
US FDA• GRAFAPEX
CRLComplete Response Letter
Complete Response Letter Ardelyx, Inc. (Jul 28, 2021)
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.
IssuedJul 28, 2021
US FDA• XPHOZAH
CRLComplete Response Letter
Complete Response Letter lterum Therapeutics U.S. Ltd. (Jul 23, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 23, 2021
US FDA• ORLYNVAH
CRLComplete Response Letter
Complete Response Letter Provention Bio, Inc. (Jul 2, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence, 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 2, 2021
US FDA• TZIELD
CRLComplete Response Letter
Complete Response Letter Cyclomedica Australia Pty Ltd. (Jun 25, 2021)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Safety and adverse events, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 25, 2021
US FDA• TECHNEGAS KIT
CRLComplete Response Letter
Complete Response Letter MediWound, Ltd. (Jun 25, 2021)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 25, 2021
US FDA• NEXOBRID

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Complete Response Letter HQ Specialty Pharma Corporation (Sep 14, 2021)

Complete Response Letter CellTrans Inc. (Aug 18, 2021)

Complete Response Letter Kashiv BioSciences, LLC (Aug 11, 2021)

Complete Response Letter LLC (Aug 5, 2021)

Complete Response Letter Spectrum Pharmaceuticals, Inc. (Aug 3, 2021)

Complete Response Letter Kashiv BioSciences, LLC (Aug 2, 2021)

Complete Response Letter medac Gesellschaft fur klinische Spezialpraparate mbH (Jul 30, 2021)

Complete Response Letter Ardelyx, Inc. (Jul 28, 2021)

Complete Response Letter lterum Therapeutics U.S. Ltd. (Jul 23, 2021)

Complete Response Letter Provention Bio, Inc. (Jul 2, 2021)

Complete Response Letter Cyclomedica Australia Pty Ltd. (Jun 25, 2021)

Complete Response Letter MediWound, Ltd. (Jun 25, 2021)