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FDA Drug Application 021476 by SUNOVION PHARMS INC

Application Number021476
Application Type New Drug Application
Sponsor ApplicantSUNOVION PHARMS INC
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
AP012/15/2004N10882000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021476ltr.pdf 12/30/2004
AP012/15/2004N10904000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf 12/30/2004
AP012/15/2004N11456000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta.cfm 4/27/2005
AP012/15/2004N16050000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP012/15/2004N24009000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134691.pdf 11/19/2009
AP01/29/2008SLR18974005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf 1/30/2008
AP01/29/2008SLR18978005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s005ltr.pdf 1/30/2008
AP01/29/2008SLR18975008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf 1/30/2008
AP01/29/2008SLR18979008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s008ltr.pdf 1/30/2008
AP04/6/2009SCP22227012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021476s012ltr.pdf 4/10/2009
AP04/6/2009SCP22276012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf 4/16/2009
AP09/30/2009S       
AP01/26/2012SLR31592021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476s021ltr.pdf 1/31/2012
AP010/10/2012SLR34048024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf 10/12/2012
AP010/10/2012SLR34081024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf 10/12/2012
AP04/4/2014SCM       
AP010/10/2012SE534049026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf 10/12/2012
AP010/10/2012SE534082026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf 10/12/2012
AP02/16/2015SCM       
AP02/3/2014SLR38465028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf 2/6/2014
AP02/3/2014SLR38485028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s028ltr.pdf 2/10/2014
AP05/29/2014SCM       
AP05/15/2014SLR39312030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf 5/16/2014
AP05/15/2014SLR39328030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s030ltr.pdf 5/20/2014
AP011/3/2014SCM       
AP08/27/2015SCM       
AP010/5/2016SCM       




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