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FDA Drug Application 021008 by NOVARTIS

Application Number021008
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/25/1998N884000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21008ltr.pdf 11/25/1998
AP011/25/1998N885000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021008.cfm 11/25/1998
AP011/25/1998N886000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21008lbl.pdf 11/25/1998
AP05/17/1999SLR       
AP07/13/1999SCM       
AP07/2/2001SLR       
AP01/3/2002SCM       
AP05/13/2002SCM       
AP04/19/2004SB       
AP012/18/2003SCS7358007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21008scs007ltr.pdf 12/23/2003
AP04/19/2004SCS8452010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008scs010ltr.pdf 4/29/2004
AP04/19/2004SCS8465010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21008scs010_sandostatin_lbl.pdf 5/3/2004
AP010/14/2004SLR10426015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008s015ltr.pdf 10/18/2004
AP05/10/2006SE514099018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf 5/16/2006
AP05/10/2006SE514109018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf 5/16/2006
AP05/10/2006SLR14110019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf 5/16/2006
AP05/10/2006SLR14098019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf 5/16/2006
AP03/3/2008SE119359021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021008s021lbl.pdf 3/5/2008
AP03/3/2008SE119379021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021008s021ltr.pdf 3/5/2008
AP01/25/2010SLR24715023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf 2/4/2010
AP01/25/2010SLR24736023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf 2/5/2010
AP09/30/2011SLR30177025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021008s025lbl.pdf 9/30/2011
AP09/30/2011SLR30194025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021008s025ltr.pdf 10/3/2011
AP011/30/2012SCM       
AP05/19/2014SLR43977028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021008Orig1s028.pdf 9/23/2015
AP05/19/2014SLR39332028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021008Orig1s028ltr.pdf 5/20/2014
AP05/19/2014SLR39415028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s028lbl.pdf 6/2/2014
AP01/30/2014SCM       
AP07/17/2014SCM39921030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s030lbl.pdf 7/22/2014
AP08/21/2014SCM       
AP05/18/2015SCM       
AP05/20/2016SCM       
AP07/22/2016SCM46602035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021008s035lbl.pdf 7/25/2016




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