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FDA Drug Application 022268 by NOVARTIS

Application Number022268
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
AP04/7/2009N22234000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022268s000ltr.pdf 4/14/2009
AP04/7/2009N22279000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022268lbl.pdf 4/16/2009
AP04/7/2009N22906000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000TOC.cfm 7/8/2009
AP04/7/2009N22907000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000_SumR.pdf 7/8/2009
AP02/17/2010SLR24830001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022268s001ltr.pdf 2/23/2010
AP02/17/2010SLR24833001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022268s001lbl.pdf 2/23/2010
AP08/6/2012SLR33406003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022268s003lbl.pdf 8/7/2012
AP08/6/2012SLR33409003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022268Orig1s003ltr.pdf 8/7/2012
AP04/29/2013SLR35899004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022268Orig1s004ltr.pdf 5/1/2013
AP04/29/2013SLR35922004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022268s004lbl.pdf 5/1/2013
AP04/3/2013SCM       
AP04/5/2013SCM       
AP011/18/2013SCM       
AP04/17/2014SCM       
AP05/6/2014SCM       
AP08/12/2014SCM       
AP01/20/2015SCM       
AP03/19/2015SLR42219012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022268Orig1s012ltr.pdf 3/20/2015
AP03/19/2015SLR42225012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022268s012lbl.pdf 3/20/2015
AP09/2/2015SCM       
AP01/6/2016SCM       
AP06/1/2016SCM       




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