Back to FDA Applications sponsored by ONY

FDA Drug Application 020521 by ONY

Application Number020521
Application Type New Drug Application
Sponsor ApplicantONY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/1/1998N55000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20521ltr.pdf 7/1/1998
AP07/1/1998N56000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf 7/1/1998
AP07/1/1998N1893000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20521_Infasurf.cfm 7/1/1998
AP03/17/1999SCM       
AP010/14/1999SCE       
AP02/23/2000SCS       
AP05/18/2000SCS       
AP04/18/2002SCS       
AP04/18/2002SCS       
AP012/12/2002SCM9114008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20521scm008ltr.pdf 6/7/2004
AP011/20/2001SCS       
AP02/19/2002SCS       
AP09/13/2002SCS       
AP07/1/2011SLR29420024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf 7/6/2011
AP07/1/2011SLR29438024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020521s024ltr.pdf 7/7/2011
AP012/23/2013SCM       
AP010/18/2013SCM       
AP03/11/2014SCM       
AP03/9/2015SCM       
AP03/9/2015SCM       




Back to FDA Applications sponsored by ONY

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.