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FDA Drug Application 018482 by PFIZER

Application Number018482
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
AP012/31/1981N       
AP08/6/1982SCP       
AP06/17/1982SLR       
AP01/7/1983SCP       
AP03/10/1983SCM       
AP03/10/1983SCM       
AP03/22/1983SLR       
AP09/23/1983SCS       
AP04/6/1984SCE       
AP07/24/1986SLR       
AP03/22/1984SCP       
AP07/24/1986SE2       
AP011/20/1984SCP       
AP011/20/1984SES       
AP02/25/1985SLR       
AP05/30/1985SCS       
AP08/26/1985SLR       
AP08/26/1985SLR       
AP06/26/1986SCM       
AP09/17/1986SCM       
AP010/4/1995SLR       
AP06/3/1987SCE       
AP06/12/1987SCE       
AP01/13/1988SCP       
AP06/6/1988SCP       
AP010/5/1988SCS       
AP02/9/1990SCM       
AP05/18/1990SCM       
AP07/9/1992SCS       
AP04/4/1994SCM       
AP010/4/1995SLR       
AP011/30/1994SLR       
AP05/30/1995SCS       
AP09/28/1995SCS       
AP03/29/1996SCM       
AP03/22/1996SLR       
AP04/21/1997SLR       
AP08/12/1997SLR       
AP02/22/2002SLR3943043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18482s43ltr.pdf 2/22/2002
AP04/5/2000SCP       
AP09/27/2011SLR30141049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018482s049ltr.pdf 9/29/2011
AP09/27/2011SLR30164049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf 9/30/2011
AP07/25/2013SLR36632051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018482Orig1s051ltr.pdf 7/29/2013
AP07/25/2013SLR36652051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf 7/30/2013
AP01/9/2015SLR41611052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018482Orig1s052ltr.pdf 1/12/2015
AP01/9/2015SLR41735052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf 1/29/2015
AP010/3/2016SCM       




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