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FDA Drug Application 201635 by SUPERNUS PHARMS

Application Number201635
Application Type New Drug Application
Sponsor ApplicantSUPERNUS PHARMS
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
TA06/25/2012TA32992000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201635Orig1s000ltr.pdf 6/26/2012
TA06/25/2012TA36252000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000TA_ltr.pdf 6/11/2013
TA06/25/2012TA36841000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000ltr.pdf 8/20/2013
TA06/25/2012TA36852000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf 8/21/2013
TA06/25/2012TA36925000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366909.pdf 8/30/2013
TA06/25/2012TA39658000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000TOC.cfm 6/24/2014
TA06/25/2012TA39659000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000SumR.pdf 6/24/2014
TA16/7/2013TA32992000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201635Orig1s000ltr.pdf 6/26/2012
TA16/7/2013TA36252000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000TA_ltr.pdf 6/11/2013
TA16/7/2013TA36841000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000ltr.pdf 8/20/2013
TA16/7/2013TA36852000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf 8/21/2013
TA16/7/2013TA36925000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366909.pdf 8/30/2013
TA16/7/2013TA39658000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000TOC.cfm 6/24/2014
TA16/7/2013TA39659000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000SumR.pdf 6/24/2014
AP28/16/2013N32992000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201635Orig1s000ltr.pdf 6/26/2012
AP28/16/2013N36252000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000TA_ltr.pdf 6/11/2013
AP28/16/2013N36841000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000ltr.pdf 8/20/2013
AP28/16/2013N36852000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf 8/21/2013
AP28/16/2013N36925000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366909.pdf 8/30/2013
AP28/16/2013N39658000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000TOC.cfm 6/24/2014
AP28/16/2013N39659000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000SumR.pdf 6/24/2014
AP04/18/2014SCM       
AP06/20/2014SCM       
AP04/18/2014SCM       
AP04/17/2015SCM       
AP05/8/2015SLR42797007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201635Orig1s007ltr.pdf 5/13/2015
AP05/8/2015SLR43003007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201635s007lbl.pdf 6/5/2015
AP010/12/2015SCM       
AP08/18/2016TA46809011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201635Orig1s011TAltr.pdf 8/19/2016
AP03/16/2016SCM       
AP08/18/2016SE846810014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201635Orig1s014ltr.pdf 8/19/2016
AP08/18/2016SE846844014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201635s014lbl.pdf 8/22/2016




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