Back to FDA Applications sponsored by CHIESI USA INC

FDA Drug Application 020744 by CHIESI USA INC

Application Number020744
Application Type New Drug Application
Sponsor ApplicantCHIESI USA INC
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
AP011/18/1999N2649000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20744_Curosurf.cfm 7/2/2001
AP011/18/1999N174000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20744ltr.pdf 11/18/1999
AP011/18/1999N175000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf 11/18/1999
AP06/19/2001SCS       
AP02/17/2004SCS7800002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20744scs002ltr.pdf 3/3/2004
AP011/21/2002SCS       
AP03/1/2002SE82648004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20744s4ltr.pdf 3/1/2002
AP04/5/2002SCS       
AP06/3/2002SCM       
AP04/17/2002SCS       
AP012/13/2002SCM       
AP09/26/2008SLR20905019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020744s019ltr.pdf 10/1/2008
AP09/26/2008SLR20933019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020744s019lbl.pdf 10/3/2008
AP04/15/2013SCM       
AP04/15/2013SCM       
AP02/12/2014SCM       
AP010/10/2014SLR40772028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020744Orig1s028ltr.pdf 10/15/2014
AP010/10/2014SLR40788028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020744s028lbl.pdf 10/15/2014
AP010/15/2014SCM       
AP05/4/2015SCM       




Back to FDA Applications sponsored by CHIESI USA INC

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.