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FDA Drug Application 022527 by NOVARTIS

Application Number022527
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
AP09/21/2010N31182000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm284282.htm 12/21/2011
AP09/21/2010N26535000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf 9/23/2010
AP09/21/2010N26543000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022527s000ltr.pdf 9/27/2010
AP09/21/2010N26586000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=22 10/1/2010
AP09/21/2010N26932000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000TOC.cfm 11/12/2010
AP09/21/2010N27916000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000sumr.pdf 2/17/2011
AP07/20/2011SE829594002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf 7/25/2011
AP07/20/2011SE829602002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022527s002ltr.pdf 7/25/2011
AP07/1/2011SLR29421003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s003lbl.pdf 7/6/2011
AP03/1/2012SLR32013005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s005ltr.pdf 3/5/2012
AP03/18/2012SLR32157006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s006ltr.pdf 3/20/2012
AP03/18/2012SLR32161006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s006lbl.pdf 3/20/2012
AP05/9/2012SLR32675008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf 5/10/2012
AP05/9/2012SLR32676008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008mg.pdf 5/10/2012
AP05/9/2012SLR32681008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s008ltr.pdf 5/11/2012
AP04/30/2014SLR39189009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022527Orig1s009ltr.pdf 5/1/2014
AP04/30/2014SLR39203009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf 5/2/2014
AP05/28/2013SE836154010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022527Orig1s010ltr.pdf 5/29/2013
AP05/28/2013SE836245010REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM227965.pdf 6/7/2013
AP05/1/2015SLR42719013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s013ltr.pdf 5/4/2015
AP05/1/2015SLR42723013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s013lbl.pdf 5/4/2015
AP08/22/2014SCM       
AP05/14/2015S42832015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s015ltr.pdf 5/19/2015
AP07/2/2015SLR43252016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf 7/6/2015
AP07/2/2015SLR43307016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s016ltr.pdf 7/10/2015
AP02/19/2016SLR45230018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s018ltr.pdf 2/23/2016
AP02/19/2016SLR45241018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf 2/23/2016
AP08/4/2015SLR43579019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s019ltr.pdf 8/6/2015
AP08/4/2015SLR43587019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf 8/6/2015




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