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FDA Drug Application 018422 by PFIZER PHARMS

Application Number018422
Application Type New Drug Application
Sponsor ApplicantPFIZER PHARMS
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
AP012/21/1981N       
AP05/5/1982SCS       
AP06/1/1982SLR       
AP09/26/1983SCM       
AP08/22/1984SCS       
AP011/20/1986SCS       
AP012/20/1985SCS       
AP012/10/1985SCM       
AP04/4/1986SLR       
AP08/26/1987SCP       
AP011/3/1987SCS       
AP01/28/1988SCM       
AP011/3/1987SCM       
AP02/3/1988SCS       
AP02/3/1988SCM       
AP05/25/1988SCS       
AP01/17/1989SE1       
AP012/1/1988SCM       
AP011/15/1988SCM       
AP06/4/1990SLR       
AP05/30/1989SCM       
AP05/30/1989SCM       
AP01/3/1990SCM       
AP01/29/1990SCM       
AP03/16/1992SLR       
AP012/2/1992SLR       
AP03/24/1995SLR       
AP012/3/1998SLR       
AP03/24/1995SLR       
AP03/24/1995SLR       
AP07/18/1997SCM       
AP08/7/2001SLR5236040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf 4/14/2003
AP08/7/2001SLR9178040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf 6/8/2004
AP08/7/2001SLR9179041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf 6/8/2004
AP08/7/2001SLR5235041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf 4/14/2003
AP09/26/2002SCS       
AP01/15/2003SLR4764043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf 1/15/2003
AP03/30/2004SLR8312045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18422slr045ltr.pdf 4/7/2004
AP07/14/2009SLR22979048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018422s048ltr.pdf 7/17/2009
AP07/14/2009SLR22990048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf 7/17/2009
AP09/27/2010SLR26553050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf 9/27/2010
AP09/27/2010SLR26556050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018422s050ltr.pdf 9/29/2010
AP010/31/2013SLR37677053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf 11/1/2013
AP010/31/2013SLR37701053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018422Orig1s053ltr.pdf 11/6/2013
AP011/5/2014SLR40955054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018422Orig1s054ltr.pdf 11/7/2014
AP011/5/2014SLR40961054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf 11/7/2014
AP04/6/2016SLR45612055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018422s055lbl.pdf 4/7/2016
AP04/6/2016SLR45621055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018422Orig1s055ltr.pdf 4/8/2016




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