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FDA Drug Application 018989 by PFIZER

Application Number018989
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/1984N       
AP012/18/1984SCF       
AP09/17/1985SCM       
AP010/19/1985SCM       
AP010/5/1984SCS       
AP05/30/1986SCM       
AP012/24/1985SCP       
AP07/5/1986SLR       
AP05/25/1988SCP       
AP02/1/1988SCP       
AP05/25/1988SCP       
AP01/17/1987SCM       
AP01/6/1987SCM       
AP05/25/1988SCS       
AP05/25/1988SCM       
AP05/25/1988SCM       
AP05/2/1988SCP       
AP04/25/1991SCP       
AP02/14/1989SCS       
AP06/28/1989SCM       
AP04/25/1991SCS       
AP02/26/1993SCS       
AP08/24/1990SCP       
AP03/11/1994SLR       
AP03/11/1994SLR       
AP010/18/1993SCM       
AP010/18/1993SCS       
AP010/24/1994SCP       
AP09/7/1994SCM       
AP04/4/1995SCF       
AP08/1/1995SCM       
AP04/3/1997SCS       
AP012/3/1996SCS       
AP012/19/1996SCF       
AP010/14/1998SCM       
AP011/19/1999SCS       
AP010/4/1999SCM       
AP011/15/2000SLR       
AP09/7/2001SCS5421053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf 4/23/2003
AP08/2/2001SCS       
AP04/24/2002SCS8585055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf 5/26/2004
AP04/24/2002SCS8586055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf 5/26/2004
AP09/26/2003SCP6727056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf 9/30/2003
AP09/26/2003SCP6728056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf 9/30/2003
AP07/16/2004SLR9795058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18989s058ltr.pdf 7/21/2004
AP04/17/2006SLR13952060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s060ltr.pdf 4/20/2006
AP04/4/2006SLR13881061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s061ltr.pdf 4/7/2006
AP05/1/2007SLR16436067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018989s067ltr.pdf 5/7/2007
AP05/1/2007SLR16449067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf 5/7/2007
AP06/12/2008SLR20000070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018989s070ltr.pdf 6/13/2008
AP05/19/2009SLR22621073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018989s073ltr.pdf 5/26/2009
AP04/26/2011SLR28614079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018989s079ltr.pdf 4/28/2011
AP04/26/2011SLR32235079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf 3/27/2012
AP09/1/2010SLR26380080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018989s080ltr.pdf 9/7/2010
AP05/18/2015SCM       
AP012/16/2015SCM44816084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018989Orig1s084ltr.pdf 12/18/2015
AP012/16/2015SCM44858084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf 12/22/2015
AP04/29/2016SCM       




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