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FDA Drug Application 017783 by PFIZER

Application Number017783
Application Type New Drug Application
Sponsor ApplicantPFIZER
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
AP05/8/1984N       
AP03/15/1985SCF       
AP010/22/1985SCE       
AP011/18/1985SLR       
AP010/16/1985SCM       
AP03/4/1987SCP       
AP09/15/1986SCM       
AP03/31/1987SFP       
AP05/14/1987SCM       
AP08/6/1991SCM       
AP05/11/1993SCF       
AP05/19/1993SLR       
AP011/24/1993SCM       
AP012/11/1997SCM       
AP08/6/1999SLR       
AP012/15/1999SCP       
AP010/27/2008SCA21097019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf 10/29/2008
AP010/27/2008SCA21146019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf 11/7/2008
AP08/27/2009SLR23371020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf 9/17/2009
AP08/27/2009SLR23961020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf 11/19/2009
AP02/7/2011SLR27762021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf 2/7/2011
AP02/7/2011SLR27765021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf 2/9/2011
AP010/15/2013SLR37427025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf 10/16/2013
AP010/15/2013SLR37509025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf 10/22/2013
AP08/18/2016SLR46816026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017783Orig1s026ltr.pdf 8/19/2016
AP08/18/2016SLR46843026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017783s026lbl.pdf 8/22/2016




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