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FDA Drug Application 050791 by NOVARTIS

Application Number050791
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/27/2004N7793000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50791ltr.pdf 3/3/2004
AP02/27/2004N11460000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50-791_Myfortic.cfm 4/27/2005
AP02/27/2004N23598000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172735.pdf 10/16/2009
AP02/27/2004N33857000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 9/27/2012
AP02/27/2004N22965000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm 7/15/2009
AP011/2/2007SLR18335001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050791s001lbl.pdf 11/7/2007
AP011/2/2007SLR18363001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050791s001ltr.pdf 11/8/2007
AP05/9/2008SLR19834002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s002ltr.pdf 5/14/2008
AP05/9/2008SLR19844002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s002lbl.pdf 5/16/2008
AP012/15/2008SLR21387004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s004ltr.pdf 12/19/2008
AP012/15/2008SLR21466004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s004lbl.pdf 1/2/2009
AP09/25/2012SLR33862005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791Orig1s005ltr.pdf 9/27/2012
AP03/27/2009SLR22153006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s006ltr.pdf 4/1/2009
AP07/10/2009SLR22947007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s007lbl.pdf 7/14/2009
AP07/10/2009SLR22991007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s007ltr.pdf 7/17/2009
AP010/8/2009SLR23590008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s008lbl.pdf 10/14/2009
AP010/8/2009SLR23763008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s008ltr.pdf 11/9/2009
AP010/27/2010SLR26820011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050791s011lbl.pdf 10/28/2010
AP010/27/2010SLR26878011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050791s011ltr.pdf 11/3/2010
AP05/1/2013SLR35951012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s012ltr_corrected.pdf 5/7/2013
AP05/1/2013SLR36015012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s012lbl.pdf 5/9/2013
AP06/22/2012SLR32994014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791s014ltr.pdf 6/26/2012
AP06/22/2012SLR33021014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014lbl.pdf 6/26/2012
AP06/22/2012SLR33022014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014mg.pdf 6/26/2012
AP02/8/2013SCM       
AP05/1/2013SCM       
AP09/27/2013SLR37274018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf 9/30/2013
AP09/27/2013SLR37294018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019ltr.pdf 10/1/2013
AP09/27/2013SLR37295019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019ltr.pdf 10/1/2013
AP09/27/2013SLR37273019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s019lbl.pdf 9/30/2013
AP08/4/2015SCM43632021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s021ltr.pdf 8/12/2015
AP011/13/2015SE844484022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s022ltr.pdf 11/16/2015
AP012/23/2015SCM       
AP010/27/2015SLR44328024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s024ltr.pdf 10/29/2015
AP010/27/2015SLR44329024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf 10/29/2015




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