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FDA Drug Application 020766 by HOFFMANN LA ROCHE

Application Number020766
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/23/1999N4840000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20766ltr.pdf 4/26/1999
AP04/23/1999N4841000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf 4/26/1999
AP04/23/1999N4842000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020766a.cfm 8/13/1999
AP08/31/1999SLR       
AP04/6/2000SLR       
AP04/6/2000SLR       
AP01/9/2001SCS       
AP01/29/2001SCP       
AP06/25/2001SLR5441007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf 4/23/2001
AP011/12/2001SCP17071009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020766_S009_XENICAL_CAPS_AP.pdf 7/6/2007
AP012/19/2001SCS       
AP012/19/2001SCS       
AP02/21/2002SCS       
AP03/8/2002SCM17070013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020766_S013_XENICAL_CAPS_AP.pdf 7/6/2007
AP02/27/2002SCM       
AP012/12/2003SE517050018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020766_S018_XENICAL_CAPSULES_AP.pdf 7/6/2007
AP012/12/2003SE57279018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-018ltr.pdf 12/19/2003
AP012/12/2003SE57445018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf 12/29/2003
AP010/22/2004SE810483019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766s019ltr.pdf 10/29/2004
AP010/22/2004SE810513019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf 11/1/2004
AP010/22/2004SE817074019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020766_S019_XENICAL_CAPS_AP.pdf 7/6/2007
AP07/9/2004SLR9733020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766slr020ltr.pdf 7/14/2004
AP07/9/2004SLR9740020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf 7/14/2004
AP09/2/2005SLR12741021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf 9/8/2005
AP09/2/2005SLR12742021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020766s021ltr.pdf 9/8/2005
AP09/2/2005SLR17073021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020766_S021_XENICAL_CAPS_AP.pdf 7/6/2007
AP01/5/2007SLR15617022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf 1/8/2007
AP01/5/2007SLR15644022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020766s022_ltr.pdf 1/12/2007
AP02/11/2009SLR21809026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf 2/12/2009
AP02/11/2009SLR21850026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf 2/18/2009
AP05/25/2010SLR25616028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf 5/25/2010
AP05/25/2010SLR25617028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf 5/25/2010
AP01/20/2012SLR31501029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf 1/24/2012
AP01/20/2012SLR31506029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf 1/25/2012
AP012/17/2010SCM27344030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf 12/22/2010
AP012/17/2010SCM27357030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s030ltr.pdf 12/22/2010
AP04/5/2013SCM       
AP04/2/2013SCM       
AP010/16/2013SLR37453033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020766Orig1s033ltr.pdf 10/18/2013
AP010/16/2013SLR37470033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf 10/18/2013
AP04/30/2014SCM       
AP08/7/2015SLR43609035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf 8/10/2015
AP08/7/2015SLR43615035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf 8/11/2015
AP08/12/2016SLR46775036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020766Orig1s036ltr.pdf 8/15/2016




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