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FDA Drug Application 016758 by PFIZER

Application Number016758
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/6/1970N       
AP05/1/1975SCS       
AP012/10/1980SLR       
AP07/31/2001SLR4854011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf 7/31/2001
AP07/31/2001SLR2922016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf 7/31/2001
AP05/19/2003SLR9248017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf 6/9/2004
AP04/7/2008SLR19659019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf 4/16/2008
AP04/7/2008SLR19674019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf 4/17/2008
AP07/19/2009SLR23080020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf 7/24/2009
AP07/19/2009SLR23086020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf 7/27/2009




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