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FDA Drug Application 019152 by PFIZER

Application Number019152
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/16/1986N       
AP09/24/1987SCP       
AP011/30/1988SCM       
AP011/30/1988SCM       
AP011/30/1988SCM       
AP07/20/1988SLR       
AP03/6/1991SCM       
AP08/8/1989SCP       
AP09/22/1988SLR       
AP012/15/1989SE2       
AP06/14/1989SCP       
AP03/30/1989SCM       
AP05/17/1989SCP       
AP01/19/1990SCM       
AP03/6/1991SCF       
AP07/28/1994SCM       
AP05/4/1992SCE       
AP09/3/1992SLR       
AP09/23/1992SCE       
AP03/17/1995SCM       
AP011/5/1993SCP       
AP01/13/1998SLR       
AP05/16/1997SCM       
AP012/11/1998SCM       
AP09/28/2001SLR       
AP07/14/2000SCM       
AP02/12/2001SCE       
AP02/14/2001SCS       
AP011/26/2002SCS1925030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19152scs030ltr.pdf 11/26/2002
AP07/1/2009SLR22894032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019152s032ltr.pdf 7/8/2009
AP07/1/2009SLR22931032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf 7/9/2009
AP03/31/2010SLR25183033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019152s033ltr.pdf 4/2/2010
AP03/31/2010SLR25194033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf 4/4/2010
AP012/1/2011SLR30865035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf 12/2/2011
AP012/1/2011SLR30878035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019152s035ltr.pdf 12/5/2011
AP01/10/2013SCM       
AP010/28/2013SLR37598038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019152Orig1s038ltr.pdf 10/28/2013
AP010/28/2013SLR37599038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf 10/28/2013
AP08/24/2016SLR46884039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019152Orig1s039ltr.pdf 8/25/2016
AP08/24/2016SLR46978039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf 9/6/2016




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