FDA letter monthly archive

FDA Letters Issued in January 2020

Name: FDA Letters Issued in January 2020
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in January 2020. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Recordati Rare Diseases Inc. (Jan 28, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 28, 2020
US FDA• CYSTADROPS
CRLComplete Response Letter
Complete Response Letter Ingenus Pharmaceuticals, LLC (Jan 14, 2020)
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.
IssuedJan 14, 2020
US FDA• CYCLOPHOSPHAMIDE
CRLComplete Response Letter
Complete Response Letter Sarfez Pharmaceuticals Inc. (Jan 10, 2020)
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.
IssuedJan 10, 2020
US FDA• SOAANZ

Complete Response Letter Recordati Rare Diseases Inc. (Jan 28, 2020)

Complete Response Letter Ingenus Pharmaceuticals, LLC (Jan 14, 2020)

Complete Response Letter Sarfez Pharmaceuticals Inc. (Jan 10, 2020)