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FDA Drug Application 019667 by NOVARTIS

Application Number019667
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP010/21/1988N       
AP06/23/1989SCS       
AP06/12/1991SCS3770004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019667-s04.pdf 2/19/1999
AP04/16/1990SLR       
AP07/3/1991SLR       
AP010/4/1991SLR       
AP02/28/1992SCS       
AP011/7/1995SCS       
AP010/10/1995SCS       
AP07/31/1992SLR       
AP09/30/1992SCM       
AP01/12/1993SCS       
AP05/3/1994SE1       
AP02/6/1995SCS       
AP012/18/1995SCF       
AP012/6/1994SCF       
AP02/16/1996SCS       
AP06/12/1996SCM       
AP07/16/1996SCS       
AP08/14/1996SCS       
AP010/21/1996SCS       
AP010/24/1997SCS       
AP07/24/2002SLR3227028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf 7/24/2002
AP010/24/1997SCS       
AP010/24/1997SCS       
AP010/24/1997SCE       
AP07/24/2002SLR3228032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf 7/24/2002
AP012/17/1998SCS       
AP07/31/1998SCM       
AP02/17/1999SCM       
AP02/17/1999SCM       
AP07/2/2001SLR       
AP06/21/2001SCM       
AP01/3/2002SCM       
AP05/13/2002SCM       
AP02/10/2003SCM4170042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm042ltr.pdf 2/10/2003
AP05/28/2002SCP       
AP01/17/2003SCM4168044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm044ltr.pdf 1/17/2003
AP01/17/2003SCM4169044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf 1/17/2003
AP09/2/2005SLR12735050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf 9/8/2005
AP09/2/2005SLR12736050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019667s050ltr.pdf 9/8/2005
AP08/26/2008SLR20695054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019667s054ltr.pdf 8/28/2008
AP08/26/2008SLR20701054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf 8/29/2008
AP01/25/2010SLR24714058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf 2/4/2010
AP01/25/2010SLR24735058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf 2/5/2010
AP02/4/2014SCM38487059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019667Orig1s059ltr.pdf 2/11/2014
AP03/23/2012SLR32193061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019667s061ltr.pdf 3/27/2012
AP03/23/2012SLR32219061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf 3/27/2012
AP02/20/2015SLR41900062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019667Orig1s062ltr.pdf 2/24/2015
AP02/20/2015SLR42134062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf 3/12/2015




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