Back to FDA Applications sponsored by GUERBET

FDA Drug Application 020316 by GUERBET

Application Number020316
Application Type New Drug Application
Sponsor ApplicantGUERBET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/21/1995N       
AP03/17/1997SCP       
AP010/15/1997SCM       
AP05/22/1997SCM       
AP01/4/1999SCF       
AP010/24/2000SCS       
AP012/30/2002SCS       
AP012/18/2001SCS       
AP04/17/2002SCS       
AP08/12/2002SCM       
AP01/6/2003SLR3093016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20316slr016ltr.pdf 1/6/2002
AP011/12/2006SCP15357021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020316s021LTR.pdf 11/14/2006
AP07/6/2015SLR43459028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf 7/23/2015
AP07/6/2015SLR43462028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020316Orig1s028ltr.pdf 7/23/2015




Back to FDA Applications sponsored by GUERBET

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.