Back to FDA Applications sponsored by VIRTUS PHARMS

FDA Drug Application 019781 by VIRTUS PHARMS

Application Number019781
Application Type New Drug Application
Sponsor ApplicantVIRTUS PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/14/1998N4000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19781ltr.pdf 5/14/1998
AP05/14/1998N5000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19781.cfm 5/14/1998
AP05/14/1998N6000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19781lbl.pdf 5/14/1998
AP010/15/1999SCS       
AP04/17/2000SCM       
AP04/17/2000SCM       
AP04/17/2000SCM       
AP03/1/2002SCS       
AP03/4/2004SLR7862008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr008ltr.pdf 3/10/2004
AP06/30/2009SLR22872013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf 7/6/2009
AP06/30/2009SLR22882013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010ltr.pdf 7/7/2009
AP011/1/2011SLR30482017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011ltr.pdf 11/3/2011
AP011/1/2011SLR30492017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf 11/4/2011
AP04/19/2013SCM       
AP08/13/2014SCM       
AP09/30/2014SCM       




Back to FDA Applications sponsored by VIRTUS PHARMS

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.