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FDA Drug Application 022334 by NOVARTIS

Application Number022334
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
AP03/30/2009N22158000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022334s000ltr.pdf 4/3/2009
AP03/30/2009N22180000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf 4/3/2009
AP03/30/2009N22586000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000TOC.cfm 5/15/2009
AP03/30/2009N22587000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000_SumR.pdf 5/15/2009
AP05/13/2010SLR25562001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf 5/17/2010
AP05/13/2010SLR25581001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s001ltr.pdf 5/18/2010
AP07/9/2010SLR25955004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf 7/12/2010
AP07/9/2010SLR25968004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s004ltr.pdf 7/14/2010
AP010/29/2010SE126846006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf 11/1/2010
AP010/29/2010SE126890006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s006ltr.pdf 11/4/2010
AP05/5/2011SE128720009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf 5/6/2011
AP05/5/2011SE128758009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf 5/10/2011
AP05/5/2011SLR28721010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf 5/6/2011
AP05/5/2011SLR28757010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf 5/10/2011
AP03/30/2012SE832339014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf 4/2/2012
AP03/30/2012SE832332014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf 4/2/2012
AP03/30/2012SLR32333015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf 4/2/2012
AP03/30/2012SLR32340015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf 4/2/2012
AP07/20/2012SE833253016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf 7/20/2012
AP07/20/2012SE833254016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s016ltrRepl.pdf 7/23/2012
AP07/20/2012SE837481016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022334Orig1s016.pdf 10/21/2013
AP04/26/2012SE132539017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s017lbl.pdf 4/26/2012
AP04/26/2012SE132587017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s017ltr.pdf 5/2/2012
AP08/29/2012SLR33604018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s018ltr.pdf 8/31/2012
AP08/29/2012SLR33614018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf 8/31/2012
AP03/26/2013SCM       
AP06/21/2013SCM       
AP02/20/2014SLR38554021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf 2/21/2014
AP02/20/2014SLR38558021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf 2/21/2014
AP011/6/2013SE837728022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf 11/7/2013
AP011/6/2013SE837736022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf 11/8/2013
AP02/20/2014SLR38555023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf 2/21/2014
AP02/20/2014SLR38559023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf 2/21/2014
AP02/20/2014SLR38560024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf 2/21/2014
AP02/20/2014SLR38556024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf 2/21/2014
AP07/1/2014SLR39734025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf 7/2/2014
AP07/1/2014SLR39743025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf 7/3/2014
AP09/12/2014SCM       
AP012/18/2014SE841331027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf 12/19/2014
AP012/18/2014SE841336027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s027ltr.pdf 12/19/2014
AP010/20/2014SCM       
AP01/23/2015SLR41679029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s029ltr.pdf 1/26/2015
AP01/23/2015SLR41728029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf 1/29/2015
AP05/22/2015SE842896030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s030ltr.pdf 5/26/2015
AP05/22/2015SE842905030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s030lbl.pdf 5/27/2015
AP09/18/2015SE843937031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s031ltr.pdf 9/22/2015
AP09/18/2015SE843956031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf 9/23/2015
AP01/29/2016SE845067032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf 2/1/2016
AP01/29/2016SE845087032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf 2/2/2016
AP02/4/2016SLR45122034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s034ltr.pdf 2/5/2016
AP02/4/2016SLR45153034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf 2/11/2016
AP02/18/2016S45229035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s035ltr.pdf 2/23/2016
AP02/26/2016SE845285036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s036lbl.pdf 2/26/2016
AP02/26/2016SE845296036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s036ltr.pdf 2/29/2016
AP06/14/2016SLR46341038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s038ltr.pdf 6/16/2016
AP06/14/2016SLR46355038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf 6/17/2016




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