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FDA Drug Application 020896 by HOFFMANN LA ROCHE

Application Number020896
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
AP04/30/1998N531000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20896ltr.pdf 4/30/1998
AP04/30/1998N532000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20896.cfm 4/30/1998
AP04/30/1998N533000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20896lbl.pdf 4/30/1998
AP02/4/1999SCS       
AP02/4/1999SCM       
AP02/4/1999SCS       
AP04/2/1999SLR       
AP08/17/1999SCS       
AP04/30/2001SE12011006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda_approv.pdf 4/30/2001
AP04/30/2001SE12012006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.cfm 4/30/2001
AP03/24/2000SLR       
AP04/30/2001SLR2013009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.htm 4/30/2001
AP04/30/2001SLR2014009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.cfm 4/30/2001
AP04/30/2001SLR5458009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S6lbl.pdf 4/25/2003
AP09/7/2001SE72005010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf 9/7/2001
AP09/7/2001SE72006010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf 9/7/2001
AP09/7/2001SE72007010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-896S10S11_Xeloda.cfm 9/7/2001
AP09/7/2001SLR2008011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf 9/7/2001
AP09/7/2001SLR2009011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf 9/7/2001
AP09/7/2001SLR2010011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-896S10S11_Xeloda.cfm 9/7/2001
AP03/15/2003SLR4475012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20896slr012_xeloda_lbl.pdf 3/26/2003
AP03/15/2003SLR4476012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20896slr012ltr.pdf 3/26/2003
AP06/15/2005SE111820016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020896s016lbl.pdf 6/15/2005
AP06/15/2005SE111821016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020896s016ltr.pdf 6/16/2005
AP02/5/2011SE827768026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020896s026lbl.pdf 2/9/2011
AP02/5/2011SE827790026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020896s026ltr.pdf 2/9/2011
AP012/10/2013SE838001032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020896s032lbl.pdf 12/11/2013
AP012/10/2013SE838041032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020896Orig1s032ltr.pdf 12/16/2013
AP07/22/2014SCM       
AP010/16/2014SLR40832034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020896Orig1s034ltr.pdf 10/21/2014
AP010/16/2014SLR40847034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020896s034lbl.pdf 10/21/2014
AP01/5/2015SCM       
AP03/2/2015SLR41987036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s036ltr.pdf 3/3/2015
AP03/2/2015SLR42029036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s036lbl.pdf 3/5/2015
AP03/19/2015SLR42236037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s037ltr.pdf 3/24/2015
AP03/19/2015SLR42251037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf 3/24/2015
AP012/22/2015SCM       




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