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FDA Drug Application 017442 by PFIZER

Application Number017442
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
AP06/23/1976N       
AP07/13/1977SCS       
AP06/14/1977SLR       
AP011/27/1978SCF       
AP08/6/1982SCP       
AP01/10/1979SLR       
AP01/14/1981SLR       
AP07/30/1981SCP       
AP09/25/1981SCP       
AP011/17/1981SCS       
AP02/19/1982SCM       
AP02/19/1982SLR       
AP04/25/1986SPD       
AP011/29/1983SCS       
AP08/1/1984SCP       
AP08/3/1984SCP       
AP09/13/1984SCP       
AP08/13/1984SLR       
AP02/26/1985SLR       
AP04/25/1986SLR       
AP09/27/1985SCS       
AP06/6/1988SCS       
AP07/14/1987SCM       
AP08/29/1988SCP       
AP010/14/1988SCM       
AP08/21/1989SCM       
AP05/1/1989SLR       
AP05/10/1994SCM       
AP06/12/2001SLR3594029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17442s29ltr.pdf 6/12/2001
AP04/6/2009SLR22224033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s033ltr.pdf 4/9/2009
AP04/6/2009SLR22268033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf 4/16/2009
AP07/10/2009SLR22972035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s035ltr.pdf 7/15/2009
AP07/10/2009SLR23039035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf 7/23/2009
AP011/4/2013SLR37683041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf 11/4/2013
AP011/4/2013SLR37724041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017442Orig1s041ltr.pdf 11/7/2013
AP07/28/2014SCM       
AP02/27/2015SLR41960043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf 3/2/2015
AP02/27/2015SLR41978043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf 3/2/2015
AP01/8/2016SCM       




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