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FDA Drug Application 020818 by NOVARTIS

Application Number020818
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/6/1998N6453000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020818_diovan_toc.cfm 8/8/2003
AP03/6/1998N8920000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_APPROV.PDF 6/2/2004
AP03/6/1998N8921000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_PRNTLBL.PDF 6/2/2004
AP03/6/1998N31207000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP011/16/1998SCS       
AP02/18/1999SCM       
AP04/28/1999SCP       
AP06/16/1999SLR       
AP04/18/2000SCS       
AP03/1/2000SLR       
AP05/10/2000SCM       
AP011/2/2000SCM       
AP09/27/2001SCM       
AP010/23/2001SCM       
AP01/17/2002SCS1708012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20818s12ltr.pdf 1/17/2002
AP04/29/2002SCM       
AP011/6/2002SCS       
AP08/1/2002SCM       
AP01/15/2003SE86115016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818s016_Diovan.cfm 7/8/2003
AP01/15/2003SE88922016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818S016_Diovan_Approv.pdf 6/2/2004
AP17/7/2005SLR11976024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20818s024PiJul7.pdf 7/8/2005
AP17/7/2005SLR11989024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020818s024lbl.pdf 7/15/2005
AP17/7/2005SLR11999024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020818s024ltr.pdf 7/15/2005
AP04/28/2006SE214044027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s027LTR.pdf 5/2/2006
AP04/28/2006SE214046027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf 5/2/2006
AP011/20/2006SLR15382032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf 11/22/2006
AP011/20/2006SLR15438032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s032ltr.pdf 12/4/2006
AP09/6/2007SLR17865035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020818s035_ltr.pdf 9/11/2007
AP07/31/2008SE120499036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020818s036ltr.pdf 8/5/2008
AP04/21/2010SLR25342043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020818s043ltr.pdf 4/23/2010
AP04/21/2010SLR25433043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf 5/3/2010
AP012/12/2011SLR30926046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s046lbl.pdf 12/12/2011
AP012/12/2011SLR30975046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf 12/14/2011
AP06/3/2011SLR29076047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s047ltr.pdf 6/9/2011
AP06/3/2011SLR29276047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s047lbl.pdf 6/27/2011
AP012/12/2011SLR30976049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf 12/14/2011
AP012/12/2011SLR30927049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s049lbl.pdf 12/12/2011
AP02/16/2012SLR31812051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818s051ltr.pdf 2/17/2012
AP02/16/2012SLR31825051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf 2/17/2012
AP01/18/2012SLR31435053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf 1/23/2012
AP01/18/2012SLR31463053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf 1/23/2012
AP07/26/2012SLR33289054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf 7/30/2012
AP07/26/2012SLR33311054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s054lbl.pdf 7/30/2012
AP010/4/2012SLR33987056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s056lbl.pdf 10/5/2012
AP010/4/2012SLR33993056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818Orig1s056ltr.pdf 10/9/2012
AP03/17/2014SLR38812058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf 3/19/2014
AP03/17/2014SLR38835058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf 3/19/2014
AP04/23/2014SCM       
AP05/30/2014SCM39427060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s060ltr.pdf 6/3/2014
AP05/30/2014SCM39437060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf 6/3/2014
AP03/17/2014SLR38836062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf 3/19/2014
AP03/17/2014SLR38813062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf 3/19/2014
AP09/24/2014SLR40613064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s064ltr.pdf 9/26/2014
AP09/24/2014SLR40632064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s064lbl.pdf 9/26/2014
AP05/22/2015SCM       
AP07/27/2015SLR43533066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020818s066lbl.pdf 7/30/2015
AP011/13/2015SCM       
AP08/1/2016SCM       




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