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 97-108 of 1819 letters

CRLComplete Response Letter
Complete Response Letter Meitheal Pharmaceuticals Inc. (Dec 11, 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.
IssuedDec 11, 2024
US FDA• CONTEPO
CRLComplete Response Letter
Complete Response Letter Fresenius Kabi USA, LLC (Dec 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.
IssuedDec 11, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Sandoz Inc. (Dec 5, 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.
IssuedDec 5, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Accord Healthcare Inc. (Dec 5, 2024)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, 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.
IssuedDec 5, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Applied Therapeutics, Inc. (Nov 27, 2024)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Nonclinical evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 27, 2024
US FDA• govorestat
CRLComplete Response Letter
Complete Response Letter Astellas Pharma US, Inc (Nov 15, 2024)
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.
IssuedNov 15, 2024
US FDA• IZERVAY
CRLComplete Response Letter
Complete Response Letter Lupin Limited (Biotech Division) (Nov 14, 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.
IssuedNov 14, 2024
US FDA• ARMLUPEG
CRLComplete Response Letter
Complete Response Letter Azurity Pharmaceuticals, Inc. (Nov 4, 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.
IssuedNov 4, 2024
US FDA• BRYNOVIN
CRLComplete Response Letter
Complete Response Letter Accord BioPharma Inc. (Oct 29, 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 29, 2024
US FDA• ENNUMO
CRLComplete Response Letter
Complete Response Letter Sun Pharmaceutical Industries Limited (Oct 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.
IssuedOct 25, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Hikma Pharmaceuticals USA Inc. (Oct 21, 2024)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 21, 2024
US FDA• naloxone HCl, 4 mg, nasal spray
CRLComplete Response Letter
Complete Response Letter Bridge Regulatory Affairs, LLC (Oct 21, 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 21, 2024
US FDA• Unknown

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Complete Response Letter Meitheal Pharmaceuticals Inc. (Dec 11, 2024)

Complete Response Letter Fresenius Kabi USA, LLC (Dec 11, 2024)

Complete Response Letter Sandoz Inc. (Dec 5, 2024)

Complete Response Letter Accord Healthcare Inc. (Dec 5, 2024)

Complete Response Letter Applied Therapeutics, Inc. (Nov 27, 2024)

Complete Response Letter Astellas Pharma US, Inc (Nov 15, 2024)

Complete Response Letter Lupin Limited (Biotech Division) (Nov 14, 2024)

Complete Response Letter Azurity Pharmaceuticals, Inc. (Nov 4, 2024)

Complete Response Letter Accord BioPharma Inc. (Oct 29, 2024)

Complete Response Letter Sun Pharmaceutical Industries Limited (Oct 25, 2024)

Complete Response Letter Hikma Pharmaceuticals USA Inc. (Oct 21, 2024)

Complete Response Letter Bridge Regulatory Affairs, LLC (Oct 21, 2024)