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FDA Drug Application 202810 by SUPERNUS PHARMS

Application Number202810
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
AP010/19/2012N34144000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000lbl.pdf 10/22/2012
AP010/19/2012N34145000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf 10/22/2012
AP010/19/2012N34162000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202810Org1s000ltr.pdf 10/23/2012
AP010/19/2012N34500000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810_oxtellarxr_toc.cfm 11/29/2012
AP010/19/2012N34501000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810Orig1s000SumR.pdf 11/29/2012
AP06/14/2013SCM       
AP08/23/2013SCM       
AP09/11/2015SCM       
AP012/4/2015SLR44674005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202810Orig1s005ltr.pdf 12/8/2015
AP012/4/2015SLR44709005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf 12/8/2015
AP012/23/2015SCM       
AP06/17/2016SCM       




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