FDA letter date archive

FDA Letters Issued in 2014

Name: FDA Letters Issued in 2014
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA approval and complete response letters issued in 2014. 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 Dr. Reddy’s Laboratories, Limited- (Dec 17, 2014)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Bioequivalence and pharmacokinetics, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 17, 2014
US FDA• BORTEZOMIB
CRLComplete Response Letter
Complete Response Letter Clarus Therapeutics, Inc. (Nov 3, 2014)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 3, 2014
US FDA• JATENZO
CRLComplete Response Letter
Complete Response Letter Mylan Pharmaceuticals Inc. (Oct 23, 2014)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 23, 2014
US FDA• ABACAVIR SULFATE AND LAMIVUDINE
CRLComplete Response Letter
Complete Response Letter Armstrong Pharmaceuticals (May 22, 2014)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, 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.
IssuedMay 22, 2014
US FDA• PRIMATENE MIST
CRLComplete Response Letter
Complete Response Letter DURECT Corporation (Feb 12, 2014)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedFeb 12, 2014
US FDA• POSIMIR
CRLComplete Response Letter
Complete Response Letter RedHill Biopharma Ltd. (Jan 31, 2014)
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.
IssuedJan 31, 2014
US FDA• RIZAFILM

Complete Response Letter Dr. Reddy’s Laboratories, Limited- (Dec 17, 2014)

Complete Response Letter Clarus Therapeutics, Inc. (Nov 3, 2014)

Complete Response Letter Mylan Pharmaceuticals Inc. (Oct 23, 2014)

Complete Response Letter Armstrong Pharmaceuticals (May 22, 2014)

Complete Response Letter DURECT Corporation (Feb 12, 2014)

Complete Response Letter RedHill Biopharma Ltd. (Jan 31, 2014)