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FDA Drug Application 050608 by PFIZER

Application Number050608
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1986N       
AP08/3/1989SCG       
AP011/22/1991SCG       
AP03/27/1992SLR       
AP01/2/1992SCS       
AP04/23/1992SCS       
AP05/8/1992SCS       
AP03/24/1993SCM       
AP010/8/1992SLR       
AP011/5/1993SLR       
AP012/10/1993SCP       
AP02/12/1997SE53666019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050608ap.pdf 2/12/1997
AP05/15/1996SCS       
AP012/6/1996SCM       
AP05/29/1998SCM       
AP02/14/2001SCS       
AP03/13/2002SCM       
AP08/19/2004SLR10027026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50608s026ltr.pdf 8/25/2004
AP04/14/2008SLR19655029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050608s029ltr.pdf 4/16/2008
AP04/14/2008SLR19718029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050608s029lbl.pdf 4/23/2008
AP012/14/2012SCM       
AP03/6/2012SLR32062040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf 3/7/2012
AP03/6/2012SLR32088040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050608s040ltr.pdf 3/13/2012
AP011/17/2014SLR41025041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042ltr.pdf 11/19/2014
AP011/17/2014SLR41050041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf 11/20/2014
AP011/17/2014SLR41026042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042ltr.pdf 11/19/2014
AP011/17/2014SLR41051042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf 11/20/2014
AP02/9/2015SCM       




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