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FDA Drug Application 022250 by ACORDA

Application Number022250
Application Type New Drug Application
Sponsor ApplicantACORDA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/22/2010N24602000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf 1/24/2010
AP01/22/2010N24660000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM199168.pdf 1/29/2010
AP01/22/2010N24683000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022250s000ltr.pdf 1/29/2010
AP01/22/2010N24829000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022250s000TOC.cfm 2/23/2010
AP01/22/2010N33255000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm313009.htm 7/23/2012
AP01/22/2010N33268000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM283321.pdf 7/24/2012
AP09/30/2014SCM       
AP011/17/2011SLR30690002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022250s002ltr.pdf 11/21/2011
AP07/20/2012SLR33256003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf 7/23/2012
AP07/20/2012SLR33258003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004mg.pdf 7/23/2012
AP07/20/2012SLR33257004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf 7/23/2012
AP07/20/2012SLR33259004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004mg.pdf 7/23/2012
AP07/20/2012SLR33261004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s004ltr.pdf 7/24/2012
AP01/22/2013SLR34940006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf 1/23/2013
AP01/22/2013SLR34941006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006mg.pdf 1/23/2013
AP01/22/2013SLR34966006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s006ltr.pdf 1/24/2013
AP012/21/2012SLR34762007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s007ltr.pdf 12/26/2012
AP012/21/2012SLR34871007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf 1/11/2013
AP06/18/2013SLR36356008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s008ltr.pdf 6/20/2013
AP08/22/2014SCM       
AP010/13/2016SLR47366013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022250Orig1s013ltr.pdf 10/17/2016
AP010/13/2016SLR47374013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf 10/17/2016




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