FDA letter date archive

FDA Letters Issued in 2012

Name: FDA Letters Issued in 2012
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA approval and complete response letters issued in 2012. This archive groups source-linked letters by issue date so regulatory teams can review decisions and deficiency patterns over time.

CRLComplete Response Letter
Complete Response Letter Otsuka Pharmaceutical Company, Ltd. (Jul 26, 2012)
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.
IssuedJul 26, 2012
US FDA• ABILIFY MAINTENA KIT
CRLComplete Response Letter
Complete Response Letter Chelsea Therapeutics, Inc. (Mar 28, 2012)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 28, 2012
US FDA• NORTHERA
CRLComplete Response Letter
Complete Response Letter Bristol-Myers Squibb (Jan 17, 2012)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 17, 2012
US FDA• FARXIGA

Complete Response Letter Otsuka Pharmaceutical Company, Ltd. (Jul 26, 2012)

Complete Response Letter Chelsea Therapeutics, Inc. (Mar 28, 2012)

Complete Response Letter Bristol-Myers Squibb (Jan 17, 2012)