Back to FDA Applications sponsored by SUNOVION

FDA Drug Application 021912 by SUNOVION

Application Number021912
Application Type New Drug Application
Sponsor ApplicantSUNOVION
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/6/2006N22232000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf 4/14/2009
AP010/6/2006N22233000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912_brovana_toc.cfm 4/14/2009
AP010/6/2006N23890000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088566.pdf 11/16/2009
AP010/6/2006N15083000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf 10/11/2006
AP010/6/2006N15091000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021912s000tr.pdf 10/13/2006
AP010/6/2006N15833000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 2/20/2007
AP012/20/2007SCP18716001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf 1/8/2008
AP012/20/2007SCP18766001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf 1/9/2008
AP07/14/2011SLR29523006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf 7/18/2011
AP07/14/2011SLR29524006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf 7/18/2011
AP06/22/2010SLR       
AP06/2/2010SLR25669011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf 6/2/2010
AP06/2/2010SLR25678011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf 6/3/2010
AP02/1/2011SLR27723012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s012MedG.pdf 2/4/2011
AP02/1/2011SLR27755012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf 2/7/2011
AP02/16/2011SLR27924015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf 2/18/2011
AP02/16/2011SLR27942015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf 2/24/2011
AP02/16/2011SLR27943015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015MedG.pdf 2/24/2011
AP09/2/2011SLR29961016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf 9/7/2011
AP08/9/2012S33428018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf 8/13/2012
AP08/9/2012S33429020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf 8/13/2012
AP01/14/2013SCM       
AP02/26/2013SCM       
AP02/27/2014SE838636023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf 3/4/2014
AP02/27/2014SE838654023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf 3/4/2014
AP09/25/2014SCM       
AP08/11/2015SCM       
AP09/16/2015SCM       
AP011/6/2015SCM       
AP07/11/2016SCM       




Back to FDA Applications sponsored by SUNOVION