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FDA Drug Application 020913 by MEDICURE

Application Number020913
Application Type New Drug Application
Sponsor ApplicantMEDICURE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/14/1998N582000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20913ltr.pdf 5/14/1998
AP05/14/1998N583000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf 5/14/1998
AP05/14/1998N25705000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20913.pdf 6/4/2010
AP07/9/1999SLR3260001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF 7/9/1999
AP07/9/1999SLR3262001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf 7/9/1999
AP07/9/1999SLR8598001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm 5/26/2004
AP06/9/1999SLR       
AP01/11/2000SLR8595004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf 5/26/2004
AP04/20/2000SCP       
AP03/23/2001SLR1593006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf 3/23/2001
AP09/25/2001SLR3064007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf 9/25/2001
AP07/24/2002SLR3062008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf 7/24/2002
AP06/17/2002SLR6139009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf 7/24/2003
AP05/17/2002SCM3061010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s010ltr.pdf 5/17/2002
AP03/5/2013SCM       
AP06/6/2012SLR32857017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf 6/8/2012
AP06/6/2012SLR32880017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf 6/11/2012
AP04/21/2015SLR42634018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf 4/22/2015
AP04/21/2015SLR42672018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf 4/28/2015
AP06/16/2016SCM       
AP010/19/2016SCM       
AP08/31/2016SCM46960022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf 9/2/2016




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