FDA letter monthly archive

FDA Letters Issued in March 2020

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

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

CRLComplete Response Letter
Complete Response Letter Xellia Pharmaceuticals, ApS (Mar 20, 2020)
FDA's complete response letter contains source-text evidence related to Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 20, 2020
US FDA• VANCOMYCIN
CRLComplete Response Letter
Complete Response Letter Braintree Laboratories, Inc. (Mar 13, 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.
IssuedMar 13, 2020
US FDA• SUTAB
CRLComplete Response Letter
Complete Response Letter Shilpa Medicare Limited (Mar 10, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 10, 2020
US FDA• BORTEZOMIB

Complete Response Letter Xellia Pharmaceuticals, ApS (Mar 20, 2020)

Complete Response Letter Braintree Laboratories, Inc. (Mar 13, 2020)

Complete Response Letter Shilpa Medicare Limited (Mar 10, 2020)