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 325-336 of 1819 letters

CRLComplete Response Letter
Complete Response Letter Mylan Laboratories Limited (Feb 1, 2017)
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.
IssuedFeb 1, 2017
US FDA• ACETAMINOPHEN
CRLComplete Response Letter
Complete Response Letter Metacel Pharmaceuticals, LLC (Jan 11, 2017)
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 11, 2017
US FDA• OZOBAX / OZOBAX DS
CRLComplete Response Letter
Complete Response Letter Sun Pharma Advanced Research Company Limited (Dec 19, 2016)
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.
IssuedDec 19, 2016
US FDA• XELPROS
CRLComplete Response Letter
Complete Response Letter Ferring Pharmaceuticals, Inc. (Nov 23, 2016)
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, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 23, 2016
US FDA• MILPROSA
CRLComplete Response Letter
Complete Response Letter United Therapeutics Corporation (Oct 7, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 7, 2016
US FDA• REMODULIN
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals USA (Sep 30, 2016)
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.
IssuedSep 30, 2016
US FDA• CASSIPA
CRLComplete Response Letter
Complete Response Letter The Feinstein Institute for Medical Research (Sep 15, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Statistical analysis, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 15, 2016
US FDA• FLUORODOPA F18
CRLComplete Response Letter
Complete Response Letter Dr. Reddy’s Laboratories, SA (Aug 30, 2016)
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 30, 2016
US FDA• XEGLYZE
CRLComplete Response Letter
Complete Response Letter Ocular Therapeutix, Inc. (Jul 21, 2016)
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.
IssuedJul 21, 2016
US FDA• DEXTENZA
CRLComplete Response Letter
Complete Response Letter Sandoz Inc. (Jun 24, 2016)
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.
IssuedJun 24, 2016
US FDA• ZIEXTENZO
CRLComplete Response Letter
Complete Response Letter Salamandra, LLC (Jun 22, 2016)
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 22, 2016
US FDA• EZALLOR SPRINKLE
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals USA (Jun 1, 2016)
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 1, 2016
US FDA• ROMIDEPSIN

Page 28 of 152

1…26 27 28 29 30…152

Complete Response Letter Mylan Laboratories Limited (Feb 1, 2017)

Complete Response Letter Metacel Pharmaceuticals, LLC (Jan 11, 2017)

Complete Response Letter Sun Pharma Advanced Research Company Limited (Dec 19, 2016)

Complete Response Letter Ferring Pharmaceuticals, Inc. (Nov 23, 2016)

Complete Response Letter United Therapeutics Corporation (Oct 7, 2016)

Complete Response Letter Teva Pharmaceuticals USA (Sep 30, 2016)

Complete Response Letter The Feinstein Institute for Medical Research (Sep 15, 2016)

Complete Response Letter Dr. Reddy’s Laboratories, SA (Aug 30, 2016)

Complete Response Letter Ocular Therapeutix, Inc. (Jul 21, 2016)

Complete Response Letter Sandoz Inc. (Jun 24, 2016)

Complete Response Letter Salamandra, LLC (Jun 22, 2016)

Complete Response Letter Teva Pharmaceuticals USA (Jun 1, 2016)