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FDA Drug Application 022068 by NOVARTIS

Application Number022068
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 Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/2007N18297000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf 10/29/2007
AP010/29/2007N18391000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022068s000ltr.pdf 11/8/2007
AP010/29/2007N19460000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068TOC.cfm 3/14/2008
AP010/29/2007N20261000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068s000_SumR.pdf 7/22/2008
AP010/29/2007N23939000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089159.pdf 11/18/2009
AP03/15/2010SLR25047001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s001lbl.pdf 3/17/2010
AP03/15/2010SLR25070001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s001ltr.pdf 3/18/2010
AP08/21/2009SLR23325002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022068s002lbl.pdf 9/16/2009
AP08/21/2009SLR24577002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022068s002ltr.pdf 1/21/2010
AP06/17/2010SLR25756004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf 6/17/2010
AP06/17/2010SLR25764004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s004,s005ltr.pdf 6/22/2010
AP06/17/2010SE125757005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf 6/17/2010
AP06/17/2010SE125765005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s004,s005ltr.pdf 6/22/2010
AP01/14/2011SE727522006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s006lbl.pdf 1/14/2011
AP01/14/2011SE727553006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s006ltr.pdf 1/20/2011
AP010/26/2011SLR30453007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s007lbl.pdf 11/1/2011
AP010/26/2011SLR30457007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068Orig1s007ltr.pdf 11/1/2011
AP011/18/2011SE830742008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s008,s009ltr.pdf 11/22/2011
AP011/18/2011SE830765008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf 11/25/2011
AP011/18/2011SE830767008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009mg.pdf 11/25/2011
AP011/18/2011SLR30741009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s008,s009ltr.pdf 11/22/2011
AP011/18/2011SLR30766009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf 11/25/2011
AP011/18/2011SLR30768009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009mg.pdf 11/25/2011
AP012/20/2012SE834743011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s011lbledt2.pdf 12/21/2012
AP012/20/2012SE834758011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022068Orig1s011ltr.pdf 12/26/2012
AP012/20/2012SE835245011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s011mg.pdf 2/26/2013
AP05/1/2012SLR32598012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s012lbl.pdf 5/2/2012
AP05/1/2012SLR32599012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s012mg.pdf 5/2/2012
AP05/1/2012SLR32606012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022068s012ltr.pdf 5/3/2012
AP05/17/2013SLR36116013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s013ltr.pdf 5/22/2013
AP06/12/2013SLR36287014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s014ltr_corrected.pdf 6/13/2013
AP06/12/2013SLR36305014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s014lbledt.pdf 6/18/2013
AP08/14/2013SCM       
AP05/22/2013SLR36147016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s016ltr.pdf 5/28/2013
AP01/22/2014SE838350017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022068Orig1s017ltr.pdf 1/23/2014
AP01/22/2014SE838356017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s017lbl.pdf 1/23/2014
AP09/27/2013SLR37283018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s018ltr.pdf 10/1/2013
AP09/27/2013SLR37301018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s018lbl.pdf 10/1/2013
AP09/25/2014SLR40640019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022068Orig1s019ltr.pdf 9/29/2014
AP09/25/2014SLR40658019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s019lbl.pdf 9/30/2014
AP01/27/2015SE841709020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022068Orig1s020ltr.pdf 1/28/2015
AP01/27/2015SE841740020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s020lbl.pdf 1/30/2015
AP010/15/2015SLR44219021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022068Orig1s021ltr.pdf 10/16/2015
AP010/15/2015SLR44263021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s021lbl.pdf 10/22/2015
AP09/27/2016SLR47184023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022068Orig1s023ltr.pdf 9/28/2016
AP09/27/2016SLR47213023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022068s023lbl.pdf 9/29/2016




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