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FDA Drug Application 016584 by PFIZER

Application Number016584
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
AP07/24/1967N       
AP06/24/1974SCS       
AP05/1/1975SCS       
AP07/29/1976SCP       
AP02/18/1977SCF       
AP07/7/1978SCP       
AP07/7/1978SLR       
AP012/8/1978SCM       
AP012/11/1978SCF       
AP010/3/1979SCP       
AP09/15/1980SCF       
AP010/8/1980SCE       
AP012/10/1980SLR       
AP09/24/1982SCF       
AP03/10/1981SCF       
AP05/21/1981SCS       
AP012/10/1982SCE       
AP06/21/1984SCP       
AP06/26/1984SCM       
AP07/31/2001SLR4853047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf 7/31/2001
AP07/31/2001SLR5914047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf 6/16/2003
AP07/26/1994SCM       
AP03/27/2000SCP       
AP02/28/2001SCM       
AP07/31/2001SLR2921055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf 7/31/2001
AP05/19/2003SLR9247056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf 6/9/2004
AP04/7/2008SLR19637057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf 4/10/2008
AP04/7/2008SLR19657057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf 4/16/2008
AP08/14/2008SLR20621058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s058ltr.pdf 8/19/2008
AP08/14/2008SLR20668058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf 8/26/2008
AP07/19/2009SLR23023059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf 7/23/2009
AP07/19/2009SLR23025059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf 7/23/2009
AP012/1/2010SLR27186060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016584s060lbl.pdf 12/4/2010
AP012/1/2010SLR27196060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016584s060ltr.pdf 12/6/2010




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