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FDA Drug Application 021882 by NOVARTIS

Application Number021882
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/2/2005N13018000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021882lbl.pdf 11/3/2005
AP011/2/2005N13036000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021882ltr.pdf 11/8/2005
AP011/2/2005N13378000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021882_s000_ExjadeTOC.cfm 1/10/2006
AP04/20/2007SLR16294002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s002lbl.pdf 4/25/2007
AP04/20/2007SLR16414002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s002lltr.pdf 5/1/2007
AP012/21/2007SLR18724003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s003lbl.pdf 1/8/2008
AP012/21/2007SLR18765003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s003ltr.pdf 1/9/2008
AP010/2/2008SLR20975004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021882s004ltr.pdf 10/8/2008
AP010/2/2008SLR21007004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021882s004lbl.pdf 10/9/2008
AP04/22/2009SLR22325006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s006ltr.pdf 4/27/2009
AP04/22/2009SLR22337006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021882s006lbl.pdf 4/28/2009
AP03/5/2009SLR21980007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s007ltr.pdf 3/10/2009
AP01/28/2010SLR24698010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021882s010lbl.pdf 2/4/2010
AP01/28/2010SLR24727010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021882s010ltr.pdf 2/5/2010
AP04/11/2011SLR28523011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s011lbl.pdf 4/11/2011
AP04/11/2011SLR28536011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s011ltr.pdf 4/13/2011
AP08/10/2011SLR29747012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s012lbl.pdf 8/11/2011
AP08/10/2011SLR29766012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s012ltr.pdf 8/12/2011
AP09/14/2012SLR33783014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021882Orig1s014ltr.pdf 9/18/2012
AP09/14/2012SLR33810014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021882s014lbl.pdf 9/20/2012
AP01/23/2013SE534971015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s015lbl.pdf 1/24/2013
AP01/23/2013SE534982015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf 1/25/2013
AP01/23/2013SLR34981016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf 1/25/2013
AP05/29/2013SLR36165017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s017ltr.pdf 5/31/2013
AP05/29/2013SLR36215017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s017lbl.pdf 6/4/2013
AP011/1/2013SCM       
AP010/21/2013SLR37501019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf 10/21/2013
AP010/21/2013SLR37503019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s019ltr.pdf 10/22/2013
AP07/23/2015SLR43468021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021882Orig1s021ltr.pdf 7/24/2015
AP07/23/2015SLR43487021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021882s021lbl.pdf 7/24/2015
AP08/12/2016SLR46776024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021882Orig1s024ltr.pdf 8/15/2016
AP08/12/2016SLR46792024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021882s024lbl.pdf 8/17/2016




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