FDA letter monthly archive

FDA Letters Issued in April 2021

Name: FDA Letters Issued in April 2021
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in April 2021. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Accord Healthcare, Inc. (Apr 30, 2021)
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.
IssuedApr 30, 2021
US FDA• CARMUSTINE
CRLComplete Response Letter
Complete Response Letter Baxter Healthcare Corporation (Apr 29, 2021)
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.
IssuedApr 29, 2021
US FDA• DAPZURA RT / DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
CRLComplete Response Letter
Complete Response Letter Chiesi USA (Apr 27, 2021)
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.
IssuedApr 27, 2021
US FDA• ELFABRIO
CRLComplete Response Letter
Complete Response Letter LEO Pharma A/S (Apr 23, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 23, 2021
US FDA• ADBRY
CRLComplete Response Letter
Complete Response Letter CMP Development LLC (Apr 22, 2021)
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.
IssuedApr 22, 2021
US FDA• NORLIQVA

Complete Response Letter Accord Healthcare, Inc. (Apr 30, 2021)

Complete Response Letter Baxter Healthcare Corporation (Apr 29, 2021)

Complete Response Letter Chiesi USA (Apr 27, 2021)

Complete Response Letter LEO Pharma A/S (Apr 23, 2021)

Complete Response Letter CMP Development LLC (Apr 22, 2021)