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 109-120 of 1819 letters

CRLComplete Response Letter
Complete Response Letter Conjupro Biotherapeutics, Inc. (Oct 10, 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.
IssuedOct 10, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Zealand Pharma US, Inc. (Oct 8, 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.
IssuedOct 8, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter CSL Behring LLC (Oct 7, 2024)
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.
IssuedOct 7, 2024
US FDA• ANDEMBRY
CRLComplete Response Letter
Complete Response Letter Celltrion Inc. (Sep 30, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 30, 2024
US FDA• STEQEYMA
CRLComplete Response Letter
Complete Response Letter Regeneron Pharmaceuticals, Inc. (Aug 20, 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.
IssuedAug 20, 2024
US FDA• LYNOZYFIC
CRLComplete Response Letter
Complete Response Letter Scienture Inc. (Aug 19, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 19, 2024
US FDA• ARBLI
CRLComplete Response Letter
Complete Response Letter Antares Pharma, Inc. (Aug 16, 2024)
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.
IssuedAug 16, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Lykos Therapeutics (Aug 8, 2024)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 8, 2024
US FDA• midomafetamine
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

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Complete Response Letter Conjupro Biotherapeutics, Inc. (Oct 10, 2024)

Complete Response Letter Zealand Pharma US, Inc. (Oct 8, 2024)

Complete Response Letter CSL Behring LLC (Oct 7, 2024)

Complete Response Letter Celltrion Inc. (Sep 30, 2024)

Complete Response Letter Regeneron Pharmaceuticals, Inc. (Aug 20, 2024)

Complete Response Letter Scienture Inc. (Aug 19, 2024)

Complete Response Letter Antares Pharma, Inc. (Aug 16, 2024)

Complete Response Letter Lykos Therapeutics (Aug 8, 2024)

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)