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FDA Drug Application 200603 by SUNOVION PHARMS INC

Application Number200603
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
AP010/28/2010N26834000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf 10/29/2010
AP010/28/2010N26886000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s000ltr.pdf 11/3/2010
AP010/28/2010N27152000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm 12/3/2010
AP010/28/2010N27905000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000SumR.pdf 2/17/2011
AP010/28/2010N31190000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP010/28/2010N36598000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362201.pdf 7/24/2013
AP012/10/2010SLR27364001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s001lbl.pdf 12/23/2010
AP012/10/2010SLR27393001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s001ltr.pdf 12/28/2010
AP012/7/2011SLR30934004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf 12/13/2011
AP012/7/2011SLR30939004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf 12/13/2011
AP04/26/2012SE232548005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf 4/27/2012
AP04/26/2012SE232577005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf 5/1/2012
AP012/7/2011SLR30935006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf 12/13/2011
AP012/7/2011SLR30940006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf 12/13/2011
AP04/26/2012SLR32549007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf 4/27/2012
AP04/26/2012SLR32578007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf 5/1/2012
AP01/22/2013SLR34938009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf 1/23/2013
AP01/22/2013SLR34967009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf 1/24/2013
AP06/28/2013SE836407010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf 7/2/2013
AP06/28/2013SE836518010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf 7/9/2013
AP06/28/2013SE844494010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s010.pdf 11/17/2015
AP06/28/2013SE836408011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf 7/2/2013
AP06/28/2013SE836519011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf 7/9/2013
AP06/28/2013SE844493011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s011.pdf 11/17/2015
AP06/13/2013SCM       
AP01/22/2013SLR34939013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf 1/23/2013
AP01/22/2013SLR34968013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf 1/24/2013
AP05/21/2014SCM       
AP07/12/2013SCM36570015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s015lbl.pdf 7/17/2013
AP09/3/2013SLR36957016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Org1s016ltr.pdf 9/5/2013
AP09/3/2013SLR37216016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf 9/24/2013
AP02/28/2014SCM       
AP01/5/2015SCM       
AP07/30/2015SCM       
AP03/29/2016SCM       
AP07/8/2016SCM       




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