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FDA Drug Application 011641 by PFIZER

Application Number011641
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/28/1958N       
AP05/16/1978SCP       
AP02/24/1978SLR       
AP03/3/1981SCP       
AP05/28/1982SCS       
AP010/18/1984SPD       
AP09/4/1984SCP       
AP09/4/1984SCP       
AP09/4/1984SCS       
AP02/24/1987SCP       
AP05/12/1987SLR       
AP01/28/1993SCS       
AP011/24/1993SCM       
AP05/16/2002SLR1675058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf 5/16/2002
AP05/16/2002SLR15259058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf 10/26/2006
AP012/15/1999SCP       
AP05/16/2002SLR1676060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf 5/16/2002
AP05/16/2002SLR15260060   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf 10/26/2006
AP01/4/2004SLR7490061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11641slr061ltr.pdf 1/9/2004
AP01/4/2004SLR17052061   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/011641_S061_DIABINESE_TABLETS_AP.pdf 7/6/2007
AP010/27/2008SCA21095064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011641s064ltr.pdf 10/29/2008
AP010/27/2008SCA21143064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011641s064lbl.pdf 11/7/2008
AP08/27/2009SLR23368065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf 9/17/2009
AP08/27/2009SLR30816065   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/011641Orig1s065.pdf 10/10/2011
AP02/1/2011SLR27705066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011641s066ltr.pdf 2/4/2011
AP02/1/2011SLR27727066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf 2/4/2011




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