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 181-192 of 1819 letters

CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Jan 18, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 18, 2023
US FDA• KISUNLA
CRLComplete Response Letter
Complete Response Letter Almatica Pharma, LLC (Jan 13, 2023)
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.
IssuedJan 13, 2023
US FDA• ZOLPIDEM TARTRATE
CRLComplete Response Letter
Complete Response Letter Liqmeds Worldwide Limited (Jan 6, 2023)
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.
IssuedJan 6, 2023
US FDA• MYHIBBIN
CRLComplete Response Letter
Complete Response Letter lpsen Biopharmaceuticals Inc. (Dec 23, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, 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.
IssuedDec 23, 2022
US FDA• SOHONOS
CRLComplete Response Letter
Complete Response Letter Alvotech USA, Inc. (Dec 20, 2022)
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.
IssuedDec 20, 2022
US FDA• SIMLANDI
CRLComplete Response Letter
Complete Response Letter Spes Pharmaceuticals Inc. (Oct 19, 2022)
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 19, 2022
US FDA• FOCINVEZ
CRLComplete Response Letter
Complete Response Letter AFT Pharmaceuticals Ltd. (Jun 30, 2022)
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.
IssuedJun 30, 2022
US FDA• COMBOGESIC IV
CRLComplete Response Letter
Complete Response Letter Acer Therapeutics Inc. (Jun 15, 2022)
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.
IssuedJun 15, 2022
US FDA• OLPRUVA
CRLComplete Response Letter
Complete Response Letter Braintree Laboratories, Inc. (Jun 6, 2022)
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.
IssuedJun 6, 2022
US FDA• SUFLAVE
CRLComplete Response Letter
Complete Response Letter UGB, Inc. (May 12, 2022)
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.
IssuedMay 12, 2022
US FDA• BIMZELX
CRLComplete Response Letter
Complete Response Letter Coherus BioSciences, Inc. (Apr 29, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 29, 2022
US FDA• LOQTORZI
CRLComplete Response Letter
Complete Response Letter Teva Neuroscience, Inc. (Apr 15, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 15, 2022
US FDA• UZEDY

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Complete Response Letter Eli Lilly and Company (Jan 18, 2023)

Complete Response Letter Almatica Pharma, LLC (Jan 13, 2023)

Complete Response Letter Liqmeds Worldwide Limited (Jan 6, 2023)

Complete Response Letter lpsen Biopharmaceuticals Inc. (Dec 23, 2022)

Complete Response Letter Alvotech USA, Inc. (Dec 20, 2022)

Complete Response Letter Spes Pharmaceuticals Inc. (Oct 19, 2022)

Complete Response Letter AFT Pharmaceuticals Ltd. (Jun 30, 2022)

Complete Response Letter Acer Therapeutics Inc. (Jun 15, 2022)

Complete Response Letter Braintree Laboratories, Inc. (Jun 6, 2022)

Complete Response Letter UGB, Inc. (May 12, 2022)

Complete Response Letter Coherus BioSciences, Inc. (Apr 29, 2022)

Complete Response Letter Teva Neuroscience, Inc. (Apr 15, 2022)