Back to FDA Applications sponsored by ROCHE

FDA Drug Application 018557 by ROCHE

Application Number018557
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/28/1981N       
AP07/21/1983SCS       
AP07/21/1983SCM       
AP07/26/1983SCM       
AP010/26/1983SCS       
AP07/24/1985SLR       
AP07/24/1985SLR       
AP07/24/1985SLR       
AP07/24/1985SLR       
AP04/30/1987SLR       
AP011/3/1987SLR       
AP06/9/1993SCM       
AP08/14/1998SCP       
AP02/26/2004SLR7785015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18557slr015ltr.pdf 3/2/2004
AP02/26/2004SLR8187015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf 4/5/2004
AP02/26/2004SLR15225015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018557_S015_Fandsidar_APPROVAL PACKAGE.pdf 10/25/2006
AP04/27/2003SLR5732016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18557slr016ltr.pdf 5/29/2003




Back to FDA Applications sponsored by ROCHE

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.