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FDA Drug Application 020912 by MEDICURE

Application Number020912
Application Type New Drug Application
Sponsor ApplicantMEDICURE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/14/1998N580000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20912ltr.pdf 5/14/1998
AP05/14/1998N581000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20912lbl.pdf 5/14/1998
AP07/9/1999SLR3278001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF 7/9/1999
AP07/9/1999SLR3279001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf 7/9/1999
AP07/9/1999SLR8597001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm 5/26/2004
AP06/9/1999SLR       
AP01/11/2000SLR8596004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf 5/26/2004
AP012/15/2000SCP       
AP02/8/2001SCP       
AP03/23/2001SLR3258007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf 3/23/2001
AP09/25/2001SLR3065008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf 9/25/2001
AP07/24/2002SLR3063009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf 7/24/2002
AP01/17/2002SCM       
AP02/12/2002SCM       
AP06/17/2002SLR8594012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf 5/26/2004
AP02/28/2003SLR4253013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20912slr013ltr.pdf 3/10/2003
AP06/6/2012SLR32856018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf 6/8/2012
AP06/6/2012SLR32881018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf 6/11/2012
AP010/10/2013SE237411019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020ltr.pdf 10/11/2013
AP010/10/2013SE237441019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf 10/17/2013
AP010/10/2013SLR37442020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf 10/17/2013
AP010/10/2013SLR37412020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020ltr.pdf 10/11/2013
AP04/21/2015SLR42633021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf 4/22/2015
AP04/21/2015SLR42673021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf 4/28/2015
AP08/31/2016SCM46959024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf 9/2/2016




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