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FDA Drug Application 020796 by ORION PHARMA

Application Number020796
Application Type New Drug Application
Sponsor ApplicantORION PHARMA
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
AP010/19/1999N268000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20796LTR.PDF 12/30/1999
AP010/19/1999N269000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF 12/30/1999
AP010/19/1999N2561000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20796_Comtan.cfm 12/30/1999
AP08/14/2001SCS       
AP01/10/2002SCM       
AP01/17/2002SCP       
AP04/18/2002SCP       
AP02/2/2009SLR21727012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf 2/3/2009
AP02/2/2009SLR21762012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf 2/4/2009
AP01/30/2009SLR21728013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf 2/3/2009
AP01/30/2009SLR21763013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf 2/4/2009
AP010/11/2010SLR26617015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf 10/11/2010
AP010/11/2010SLR26654015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf 10/13/2010
AP06/13/2014SLR39548016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020796Orig1s016ltr.pdf 6/17/2014
AP06/13/2014SLR39565016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf 6/17/2014
AP01/16/2014SCM       
AP010/11/2013SCM       
AP01/16/2015SLR41647024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020796Orig1s024ltr.pdf 1/20/2015
AP01/16/2015SLR41653024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf 1/20/2015
AP010/16/2015SCM       
AP02/22/2016SLR45252026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf 2/24/2016
AP02/22/2016SLR45293026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf 2/26/2016
AP010/5/2016SCM       




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