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FDA Drug Application 021990 by NOVARTIS

Application Number021990
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA012/21/2006TA15582000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021990s000TAltr.pdf 1/8/2007
AP16/20/2007N15582000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021990s000TAltr.pdf 1/8/2007
TA012/21/2006TA16825000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021990lbl.pdf 6/25/2007
AP16/20/2007N16825000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021990lbl.pdf 6/25/2007
TA012/21/2006TA16906000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021990s000ltr.pdf 7/5/2007
AP16/20/2007N16906000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021990s000ltr.pdf 7/5/2007
TA012/21/2006TA20924000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021990_exforge_toc.cfm 10/3/2008
AP16/20/2007N20924000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021990_exforge_toc.cfm 10/3/2008
AP07/23/2008SE120291003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021990s003lbl.pdf 7/24/2008
AP07/23/2008SE120298003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021990s003ltr.pdf 7/25/2008
AP03/30/2010SLR25197007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021990s007lbl.pdf 4/4/2010
AP03/30/2010SLR25208007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021990s007ltr.pdf 4/5/2010
AP05/31/2011SLR29022013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s013ltr.pdf 6/3/2011
AP05/31/2011SLR29030013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s013lbl.pdf 6/7/2011
AP012/7/2011SLR30941014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s014lbl.pdf 12/13/2011
AP012/7/2011SLR30946014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s014ltr.pdf 12/14/2011
AP010/31/2011SLR30468016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s016ltr.pdf 11/2/2011
AP010/31/2011SLR30474016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s016lbl.pdf 10/31/2011
AP01/18/2012SLR31421017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012ltr.pdf 1/20/2012
AP01/18/2012SLR31588017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s017lbl.pdf 1/30/2012
AP09/28/2012SLR33883018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s018lbl.pdf 10/1/2012
AP09/28/2012SLR33918018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990Orig1s018ltr.pdf 10/2/2012
AP011/28/2012SLR34498019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990Orig1s019ltr.pdf 11/29/2012
AP011/28/2012SLR34586019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s019lbl.pdf 12/10/2012
AP03/17/2014SLR38817020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s020,s021ltr.pdf 3/19/2014
AP03/17/2014SLR38818021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s020,s021ltr.pdf 3/19/2014
AP03/17/2014SLR38837021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s020s021lbl.pdf 3/19/2014
AP06/9/2014SCM       
AP09/24/2014SLR40603024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s024ltr.pdf 9/25/2014
AP09/24/2014SLR40634024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s024lbl.pdf 9/26/2014
AP05/22/2015SCM       
AP07/28/2015SLR43521026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021990Orig1s026ltr.pdf 7/30/2015
AP07/28/2015SLR43542026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021990s026lbl.pdf 7/30/2015
AP012/21/2015SCM       
AP02/12/2016SCM       




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