Back to FDA Applications sponsored by AUXILIUM PHARMS LLC

FDA Drug Application 019790 by AUXILIUM PHARMS LLC

Application Number019790
Application Type New Drug Application
Sponsor ApplicantAUXILIUM PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/2/1988N       
AP08/20/1991SCS       
AP012/9/1991SCS       
AP03/13/1996SLR       
AP03/12/1996SCM       
AP05/31/1996SCM       
AP07/9/1998SCM       
AP01/13/1999SLR       
AP010/29/1999SCM       
AP01/30/2002SLR       
AP010/24/2014SLR40881011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019790Orig1s011ltr.pdf 10/27/2014
AP010/24/2014SLR41020011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf 11/18/2014




Back to FDA Applications sponsored by AUXILIUM PHARMS LLC

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.