FDA letter monthly archive

FDA Letters Issued in June 2021

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

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

CRLComplete Response Letter
Complete Response Letter Cyclomedica Australia Pty Ltd. (Jun 25, 2021)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Safety and adverse events, 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 25, 2021
US FDA• TECHNEGAS KIT
CRLComplete Response Letter
Complete Response Letter MediWound, Ltd. (Jun 25, 2021)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, 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 25, 2021
US FDA• NEXOBRID
CRLComplete Response Letter
Complete Response Letter Shilpa Medicare Limited (Jun 24, 2021)
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 24, 2021
US FDA• PEMETREXED
CRLComplete Response Letter
Complete Response Letter Orphazyme A/S (Jun 17, 2021)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Nonclinical evidence, Statistical analysis, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 17, 2021
US FDA• MIPLYFFA
CRLComplete Response Letter
Complete Response Letter Nevakar, Inc. (Jun 14, 2021)
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 14, 2021
US FDA• NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Complete Response Letter Cyclomedica Australia Pty Ltd. (Jun 25, 2021)

Complete Response Letter MediWound, Ltd. (Jun 25, 2021)

Complete Response Letter Shilpa Medicare Limited (Jun 24, 2021)

Complete Response Letter Orphazyme A/S (Jun 17, 2021)

Complete Response Letter Nevakar, Inc. (Jun 14, 2021)