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FDA Drug Application 021283 by NOVARTIS

Application Number021283
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/18/2001N5572000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21283lbl.pdf 5/5/2003
AP07/18/2001N16823000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021283_ORIGINAL_APPROVAL_PACKAGE.PDF 6/22/2007
AP07/18/2001N31208000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP08/14/2002SE14678001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s001_Diovan.cfm 8/14/2002
AP08/14/2002SE11703001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20665se1-016,21283se1-001ltr.pdf 8/14/2002
AP08/14/2002SE11704001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf 8/14/2002
AP04/5/2002SE81705002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21283s2ltr.pdf 4/5/2002
AP04/5/2002SE81706002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283S002_Diovan_prntlbl.pdf 4/5/2002
AP04/5/2002SE81707002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s002_Diovan.cfm 4/5/2002
AP04/29/2002SCM       
AP011/6/2002SCS14224004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020665s004_diovan_toc.cfm 6/6/2006
AP011/6/2002SCS14225004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20665S004_DIOVAN_PRNTLBL.PDF 6/6/2006
AP09/13/2002SCM       
AP08/1/2002SCM       
AP08/3/2005SE116136011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021283_S011_DIOVANTOC.cfm 3/31/2007
AP08/3/2005SE112553011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021283s011ltr.pdf 8/8/2005
AP08/3/2005SE112568011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021283s011lbl.pdf 8/8/2005
AP011/30/2004SLR10726012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21283s012lbl.pdf 12/3/2004
AP011/30/2004SLR10732012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21283s012ltr.pdf 12/6/2004
AP011/22/2006SLR15421018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021283s018lbl.pdf 12/4/2006
AP011/22/2006SLR15436018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021283s018ltr.pdf 12/4/2006
AP08/17/2007SLR31990021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021283Orig1s021.pdf 3/2/2012
AP08/17/2007SLR17685021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021283s021ltr.pdf 8/22/2007
AP011/29/2007SE518610024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021283s024lbl.pdf 12/3/2007
AP011/29/2007SE518872024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021283s024ltr.pdf 1/9/2008
AP011/29/2007SE531991024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021283Orig1s024.pdf 3/2/2012
AP06/15/2009SLR22767027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021283s027ltr.pdf 6/17/2009
AP06/15/2009SLR22789027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021283s027lbl.pdf 6/22/2009
AP06/3/2011SLR29037032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s032lbl.pdf 6/7/2011
AP06/3/2011SLR29049032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021283s032ltr.pdf 6/7/2011
AP012/12/2011SLR30925033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf 12/12/2011
AP012/12/2011SLR30971033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021283s033ltr.pdf 12/14/2011
AP02/28/2012SLR32037035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s035lbl.pdf 3/6/2012
AP02/28/2012SLR31961035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s035ltr.pdf 2/29/2012
AP01/18/2012SLR31434036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf 1/23/2012
AP01/18/2012SLR31462036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s036lbl.pdf 1/23/2012
AP07/26/2012SLR33288037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf 7/30/2012
AP07/26/2012SLR33310037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s037lbl.pdf 7/30/2012
AP010/4/2012SLR33988039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s039lbl.pdf 10/5/2012
AP010/4/2012SLR33994039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s039ltr.pdf 10/9/2012
AP010/18/2013SCM       
AP03/17/2014SLR38831041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf 3/19/2014
AP03/17/2014SLR38815041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s041,s042ltr.pdf 3/19/2014
AP03/17/2014SLR38816042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s041,s042ltr.pdf 3/19/2014
AP03/17/2014SLR38832042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf 3/19/2014
AP09/26/2014SLR40669044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s044lbl.pdf 9/30/2014
AP09/26/2014SLR40678044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s044ltr.pdf 10/1/2014
AP07/27/2015SLR43507046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021283Orig1s046ltr.pdf 7/28/2015
AP07/27/2015SLR43535046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021283s046lbl.pdf 7/30/2015
AP07/31/2015SCM       
AP010/12/2016SCM       




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