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FDA Drug Application 022465 by NOVARTIS PHARMS CORP

Application Number022465
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/19/2009N23641000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf 10/20/2009
AP010/19/2009N23710000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188476.pdf 10/30/2009
AP010/19/2009N23719000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022465s000ltr.pdf 11/3/2009
AP010/19/2009N24584000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000TOC.cfm 1/22/2010
AP010/19/2009N24586000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000_SumR.pdf 1/22/2010
AP04/27/2010SLR25450002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022465s002ltr.pdf 5/3/2010
AP04/27/2010SLR25507002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf 5/7/2010
AP010/21/2011SLR30407003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf 10/25/2011
AP010/21/2011SLR30412003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf 10/25/2011
AP010/21/2011SLR30406005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf 10/25/2011
AP010/21/2011SLR30413005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf 10/25/2011
AP04/21/2011SLR28601006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s006ltr.pdf 4/22/2011
AP01/12/2012SE831398007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s007ltr.pdf 1/17/2012
AP01/12/2012SE831475007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s007lbl.pdf 1/23/2012
AP04/26/2012SE132540010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf 4/27/2012
AP04/26/2012SE132585010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf 5/2/2012
AP03/20/2012SLR32172011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf 3/23/2012
AP03/20/2012SLR32173011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011mg.pdf 3/23/2012
AP03/20/2012SLR32181011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s011ltr.pdf 3/26/2012
AP04/26/2012SLR32541012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf 4/27/2012
AP04/26/2012SLR32586012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf 5/2/2012
AP011/15/2012SLR34414013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465Orig1s013ltr.pdf 11/16/2012
AP011/15/2012SLR34420013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013lbl.pdf 11/16/2012
AP011/15/2012SLR34421013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013mg.pdf 11/16/2012
AP08/14/2013SLR36787014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf 8/15/2013
AP08/14/2013SLR36813014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf 8/16/2013
AP08/14/2013SLR36788015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf 8/15/2013
AP08/14/2013SLR36814015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf 8/16/2013
AP08/14/2013SLR36789016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf 8/15/2013
AP08/14/2013SLR36815016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf 8/16/2013
AP011/27/2013SLR37959017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s017lbl.pdf 12/3/2013
AP011/27/2013SLR38099017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s017ltr.pdf 12/18/2013
AP06/3/2014SLR39441018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s018lbl.pdf 6/4/2014
AP06/3/2014SLR39447018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s018ltr.pdf 6/5/2014
AP011/18/2014SE841036019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s019ltr.pdf 11/20/2014
AP011/18/2014SE841056019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf 11/20/2014
AP03/31/2015SLR42363020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf 4/1/2015
AP03/31/2015SLR42374020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf 4/2/2015
AP03/31/2015SLR42379020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s020ltr.pdf 4/2/2015
AP14/1/2015SLR42363020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf 4/1/2015
AP14/1/2015SLR42374020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf 4/2/2015
AP14/1/2015SLR42379020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s020ltr.pdf 4/2/2015
AP09/22/2015SLR43980021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s021ltr.pdf 9/24/2015
AP09/22/2015SLR44128021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf 10/6/2015
AP05/20/2016SLR46103022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf 5/23/2016
AP05/20/2016SLR46117022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s022ltr.pdf 5/24/2016
AP08/5/2016SLR46738023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s023ltr.pdf 8/9/2016
AP08/5/2016SLR46750023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s023lbl.pdf 8/9/2016




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