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FDA Drug Application 021485 by ORION PHARMA

Application Number021485
Application Type New Drug Application
Sponsor ApplicantORION PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/11/2003N5977000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21485ltr.pdf 6/22/2003
AP06/11/2003N5985000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21485_stalevo_lbl.pdf 6/22/2003
AP06/11/2003N8033000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_Stalevo.cfm 3/24/2004
AP06/11/2003N26147000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm206513.htm 8/9/2010
AP02/2/2009SLR21720008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf 2/3/2009
AP13/3/2009SLR21720008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf 2/3/2009
AP02/2/2009SLR21781008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 2/4/2009
AP13/3/2009SLR21781008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 2/4/2009
AP02/2/2009SLR21957008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf 3/5/2009
AP13/3/2009SLR21957008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf 3/5/2009
AP02/2/2009SLR22078008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 3/23/2009
AP13/3/2009SLR22078008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 3/23/2009
AP08/2/2007SCF17474011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021485s011lbl.pdf 8/3/2007
AP08/2/2007SCF17568011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/0214855s011ltr.pdf 8/7/2007
AP02/2/2009SLR22079012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 3/23/2009
AP13/3/2009SLR22079012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 3/23/2009
AP02/2/2009SLR22080012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 2/4/2009
AP13/3/2009SLR22080012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf 2/4/2009
AP02/2/2009SLR21956012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf 3/5/2009
AP13/3/2009SLR21956012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf 3/5/2009
AP02/2/2009SLR21719012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf 2/3/2009
AP13/3/2009SLR21719012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf 2/3/2009
AP08/29/2008SCF20727016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf 8/29/2008
AP08/29/2008SCF20728016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s016ltr.pdf 9/3/2008
AP09/26/2008SLR20908017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s017ltr.pdf 10/1/2008
AP09/26/2008SLR20934017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s017lbl.pdf 10/3/2008
AP010/11/2010SLR26616020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021485s20lbl.pdf 10/11/2010
AP010/11/2010SLR26655020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf 10/13/2010
AP04/5/2013SCM       
AP07/18/2014SLR39955028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf 7/23/2014
AP07/18/2014SLR39985028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf 7/24/2014
AP07/18/2014SLR39986029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf 7/24/2014
AP07/18/2014SLR39956029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf 7/23/2014
AP01/16/2014SCM       
AP02/14/2014SCM       
AP02/22/2016SLR45253033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf 2/24/2016
AP02/22/2016SLR45272033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf 2/25/2016
AP01/29/2016SCM       
AP02/18/2016SCM45249035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf 2/23/2016
AP02/25/2016SCM       




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